A Study to Evaluate the Efficacy and Safety of XyloCore, a Glucose Sparing Experimental Solution, for Peritoneal Dialysis (ELIXIR)

2024-513562-19-00 Protocol IP-001-18 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 30 Aug 2023 · Status Ongoing, recruiting · 5 EU/EEA countries · 38 sites · Protocol IP-001-18

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 175
Countries 5
Sites 38

End-Stage Kidney Disease

To demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/V urea

Key facts

Sponsor
Iperboreal Pharma S.r.l.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Male Urogenital Diseases [C12]
Trial duration
30 Aug 2023 → ongoing
Decision date (initial)
2024-07-03
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Iperboreal Pharma S.r.l. · Vivisol S.r.l.

External identifiers

EU CT number
2024-513562-19-00
EudraCT number
2019-004183-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To demonstrate the non-inferiority of XyloCore compared to the standard treatment of glucose PD solutions, with regards to the weekly Kt/V urea

Secondary objectives 8

  1. Evaluate changes in LDL, HDL and total cholesterol, serum triglycerides, HbA1c and insulin
  2. Evaluate changes in hemoglobin and EPO requirements
  3. Evaluate changes in patients’ subjective assessment of fatigue (by Chalder Fatigue Scale)
  4. Evaluate changes in Peritoneal Ultrafiltration
  5. Evaluate changes in blood pressure
  6. Evaluate changes in diuresis
  7. Evaluate changes in Residual Kidney Function
  8. Evaluate patients' safety

Conditions and MedDRA coding

End-Stage Kidney Disease

VersionLevelCodeTermSystem organ class
21.1 LLT 10014646 End stage renal disease (ESRD) 10038359

Study design 3 periods

#TitleAllocationBlindingRoles blindedArms
1 Screening
Evaluation of Inc/Exc criteria
 Not Applicable None Intervention: Xylocore
Control: Glucose-based comparators
2 Treatment
6 months treatment
 Randomised Controlled None Intervention: Xylocore
Control: Glucose-based comparators
3 After-treatment Follow-up
Only for Sweden
 Randomised Controlled None Intervention: Xylocore
Control: Glucose-based comparators

Regulatory references

Scientific advice from competent authorities
Federal Institute For Drugs And Medical Devices
Plan to share IPD
No
IPD plan description
Not applicable

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

  1. Age ≥18 years
  2. Diagnosis of ESRD and treated with CAPD in the last 3 months
  3. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events
  4. Have not experienced peritonitis episodes in the last 3 months
  5. In treatment with Extraneal (nocturnal long-dwell exchange for at least one month)
  6. In treatment with 1, 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
  7. Weekly Kt/V urea measurement > 1.7
  8. Followed-up/treated by the participating clinical Center/Investigator in the last three months
  9. Understanding the nature of the study and providing informed consent to participate in the study

Exclusion criteria 17

  1. History of drug or alcohol abuse in the six months prior to entering the protocol
  2. In treatment with androgens
  3. Clinically significant abnormal liver function test (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)
  4. Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc)
  5. Expected patient’s survival shorter than trial duration
  6. L-Carnitine therapy in the month prior to entering the protocol
  7. Have used any investigational drug in the 3 months prior to entering the protocol
  8. Female patients who are pregnant or breast-feeding
  9. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception
  10. Patients affected by Primary Hyperoxaluria as per known medical history
  11. Patients affected by gout, who have had one or more flares of gout during the last 12 months before the screening, with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)
  12. Patients with a major cardiovascular event in the last 3 months
  13. Patients with advanced cardiac failure (NYHA 4)
  14. Hypersensitivity to any of the constituents of the study IMPs
  15. Any contraindication to the prescribed Peritoneal Dialysis solutions (for long-dwell and short-dwell exchange) as per each product SmPC
  16. Participants with medical history of oxalate or lactate abnormalities considered clinically significant by the investigator
  17. History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant AE or interfere with study assessments during the course of the trial as determined by the clinical judgment of the investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Weekly Kt/V urea (V1, V3, V4, V5)

Secondary endpoints 7

  1. Glycemic and lipid metabolic parameters: LDL, HDL and total cholesterol, serum triglycerides, insulin (V1, V3, V4, V5)
  2. EPO requirements (V1, V3, V5)
  3. Patients’ subjective assessment of fatigue (V1, V3, V5)
  4. 24h peritoneal dialysate analysis: volume, ultrafiltration, urea, creatinine (V1, V3, V4, V5)
  5. 24h urine analysis: volume, urea, creatinine (V1, V3, V4, V5)
  6. Residual Kidney Function (V1, V3, V4, V5)
  7. Safety, evaluated by physical examinations, vital signs, laboratory outcomes and adverse events (whole study)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Xylocore Medium Strength

PRD11291893 · Product

Active substance
Levocarnitine
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Not Authorised
MA holder
IPERBOREAL PHARMA S.R.L.
Paediatric formulation
No
Orphan designation
No

Xylocore High Strength

PRD11291894 · Product

Active substance
Levocarnitine
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Not Authorised
MA holder
IPERBOREAL PHARMA S.R.L.
Paediatric formulation
No
Orphan designation
No

Xylocore Low Strength

PRD11291892 · Product

Active substance
Levocarnitine
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Not Authorised
MA holder
IPERBOREAL PHARMA S.R.L.
Paediatric formulation
No
Orphan designation
No

Comparator 27

balance 1,5% Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösung

PRD792710 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25095
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dianeal PDG4 1,36 % , Peritonealdialyselösung

PRD311707 · Product

Active substance
Sodium Lactate Solution
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
42338.00.00
MA holder
BAXTER DEUTSCHLAND GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

bicaVera 4,25 % Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung

PRD735587 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25198
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

balance 2,3% Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung

PRD792707 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25096
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PHYSIONEAL 35 Glucose 2,27 % w/v / 22,7 mg/ml, Peritonealdialyselösung

PRD1606203 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
BE260477
MA holder
BAXTER SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FIXIONEAL “35 Glucosio 3,86% p/v/38,6 mg/ml” in sacca Clear-Flex Soluzione per dialisi peritoneale

PRD313416 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
036567 511
MA holder
BAXTER S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

equiBalance 1,5% glucosio, 1,75 mmol/l calcio, soluzione per dialisi peritoneale

PRD795483 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
035699040
MA holder
FRESENIUS MEDICAL CARE ITALIA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

balance 4,25% Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösung

PRD792708 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25094
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

balance 4,25% Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung

PRD792709 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25092
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dianeal PDG4 3,86 % , Peritonealdialyselösung

PRD311709 · Product

Active substance
Sodium Lactate Solution
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
42338.02.00
MA holder
BAXTER DEUTSCHLAND GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

bicaVera 2,3 % Glucose, 1,25 mmol/l Calcium Peritonealdialyselösung

PRD10627023 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
94211.00.00
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PHYSIONEAL 35 Glucose 3,86 % w/v / 38,6 mg/ml, Peritonealdialyselösung

PRD1606206 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
BE260504
MA holder
BAXTER SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PHYSIONEAL 40 Glucose 2,27 % w/v / 22,7 mg/ml, Peritonealdialyselösung

PRD1606229 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
BE211452
MA holder
BAXTER SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

bicaVera 4,25 % Glucose, 1,25 mmol/l Calcium Peritonealdialyselösung

PRD10627025 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
94212.00.00
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dianeal PDG4 2,27 % , Peritonealdialyselösung

PRD311708 · Product

Active substance
Sodium Lactate Solution
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
42338.01.00
MA holder
BAXTER DEUTSCHLAND GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PHYSIONEAL 40 Glucose 3,86 % w/v / 38,6 mg/ml, Peritonealdialyselösung

PRD1606232 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
BE213972
MA holder
BAXTER SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PHYSIONEAL 40 Glucose 1,36 % w/v / 13,6 mg/ml, Peritonealdialyselösung

PRD1606226 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
BE210217
MA holder
BAXTER SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

balance 2,3% Glucose, 1,25 mmol/l Calcium, Peritonealdialyselösung

PRD792712 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25098
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

balance 1,5% Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung

PRD792711 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25093
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

equiBalance 4,25% glucosio, 1,75 mmol/l calcio, soluzione per dialisi peritoneale

PRD973477 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
035699141
MA holder
FRESENIUS MEDICAL CARE ITALIA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

bicaVera 2,3 % Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung

PRD735586 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25197
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FIXIONEAL “35 Glucosio 2,27% p/v/22,7 mg/ml” in sacca Clear-Flex, Soluzione per dialisi peritoneale

PRD313064 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
036567 269
MA holder
BAXTER S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FIXIONEAL “35 Glucosio 1,36% p/v / 13,6 mg/ml” in sacca Clear-Flex, Soluzione per dialisi peritoneale

PRD311986 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
036567 016
MA holder
BAXTER S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

equiBalance 2,3% glucosio, 1,75 mmol/l calcio, soluzione per dialisi peritoneale

PRD973476 · Product

Active substance
Magnesium Chloride Hexahydrate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
035699091
MA holder
FRESENIUS MEDICAL CARE ITALIA S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PHYSIONEAL 35 Glucose 1,36 % w/v / 13,6 mg/ml, Peritonealdialyselösung

PRD1606200 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
BE260443
MA holder
BAXTER SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

bicaVera 1,5 % Glucose, 1,25 mmol/l Calcium Peritonealdialyselösung

PRD10627021 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
94210.00.00
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

bicaVera 1,5 % Glucose, 1,75 mmol/l Calcium, Peritonealdialyselösung

PRD735504 · Product

Active substance
Sodium Hydrogen Carbonate
Pharmaceutical form
SOLUTION FOR PERITONEAL DIALYSIS
Route of administration
INTRAPERITONEAL USE
Max daily dose
6 l litre(s)
Max total dose
6 l litre(s)
Max treatment duration
6 Month(s)
Authorisation status
Authorised
ATC code
B05DB — HYPERTONIC SOLUTIONS
Marketing authorisation
1-25196
MA holder
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Iperboreal Pharma S.r.l.

4 Total trials 3 Recruiting
Commercial
Sponsor organisation
Iperboreal Pharma S.r.l.
Address
Via L' Aquila 9, Abruzzo Abruzzo
City
Pescara
Postcode
65121
Country
Italy

Scientific contact point

Organisation
Iperboreal Pharma S.r.l.
Contact name
Arduino Arduini

Public contact point

Organisation
Iperboreal Pharma S.r.l.
Contact name
Arduino Arduini

Third parties 14

OrganisationCity, countryDuties
Arithmos S.r.l.
ORG-100047544
 Verona, Italy Code 8
Depo-pack S.r.l.
ORG-100013780
 Saronno, Italy Code 14
Distefar Del Sur S.L.
ORG-100022204
 Bollullos De La Mitacion, Spain Code 14
Specific Pharma A/S
ORG-100015041
 Copenhagen Sv, Denmark Code 14
Apoteket AB
ORG-100021562
 Solna, Sweden Code 14
Persongene S.r.l.
ORG-100051641
 Bari, Italy Laboratory analysis
Infomed Fluids S.R.L.
ORG-100001317
 Bucharest, Romania Other
Excelya Germany GmbH
ORG-100045942
 Freiburg Im Breisgau, Germany Code 10
Depo-pack S.r.l.
ORG-100013780
 Lazzate, Italy Code 14
Nubilaria S.r.l.
ORG-100047670
 Novara, Italy E-data capture
Cryolab S.r.l.
ORG-100051594
 Rome, Italy Other
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ORG-100014358
 Rome, Italy Laboratory analysis
Sintesi Research S.r.l.
ORG-100029868
 Milan, Italy On site monitoring, Code 12, Code 5, Data management
Industria Farmaceutica Galenica Senese S.r.l.
ORG-100000086
 Monteroni D'Arbia, Italy Other

Locations

5 EU/EEA countries · 38 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 20 3
Germany Ongoing, recruitment ended 15 1
Italy Ongoing, recruiting 75 15
Spain Ongoing, recruiting 40 17
Sweden Ongoing, recruiting 10 2
Rest of world
United Kingdom
 — 15 —

Investigational sites

Denmark

3 sites · Ended
Region Sjaelland
Nephrology, Sygehusvej 10, 4000, Roskilde
Aalborg University Hospital
Nephrology, Moelleparkvej 4, 9000, Aalborg
Aarhus Universitetshospital
Nephrology, J120, Palle Juul-Jensens Boulevard 165, Aarhus N

Germany

1 site · Ongoing, recruitment ended
DaVita Clinical Research Deutschland GmbH
Nephrology, Bismarckstrasse 101, Stadtmitte, Duesseldorf

Italy

15 sites · Ongoing, recruiting
Universita' Degli Studi G. D'annunzio Di Chieti
Nephrology, Via Dei Vestini 31, 66100, Chieti
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Nephrology, Piazza Luigi Miraglia 2, 80138, Naples
Azienda Ospedaliera S Maria Di Terni
Nephrology, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Ospedaliero Universitaria Di Modena
Nephrology, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliera di Padova
Nephrology, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Nephrology, Via Sergio Pansini 5, 80131, Naples
Ospedale San Giovanni Bosco
Nephrology, Piazza Del Donatore Di Sangue 3, 10154, Turin
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Nephrology, Piazza Giulio Cesare 11, Italy, Bari
IRCCS Ospedale Policlinico San Martino
Nephrology, Largo Rosanna Benzi 10, 16132, Genoa
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Nephrology, Via Della Commenda 12, 20122, Milan
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Nephrology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Sanitaria Territoriale Di Ascoli Piceno
Nephrology, Via Degli Iris 1, 63100, Ascoli Piceno
ASST Fatebenefratelli Sacco
Nephrology, Via Giovanni Battista Grassi 74, 20157, Milan
Ospedale Santa Maria Annunziata
Nephrology, Via Dell' Antella 58, 50012, Bagno A Ripoli
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Nephrology, Via Pietro Albertoni 15, 40138, Bologna

Spain

17 sites · Ongoing, recruiting
Hospital Clinico Universitario De Valencia
Nephrology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Basurto
Nephrology, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario Severo Ochoa
Nephrology, Avenida Orellana S/n, 28911, Leganes
Hospital Universitario De Navarra
Nephrology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitari De Girona Doctor Josep Trueta
Nephrology, Avinguda De Franca S/n, 17007, Girona
Hospital Universitario De Toledo
Nephrology, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Universitario Puerta De Hierro De Majadahonda
Nephrology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Fundacio Puigvert
Nephrology, Calle De Cartagena 340-350, 08025, Barcelona
Hospital Universitario Central De Asturias
Nephrology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Fundacion Jimenez Diaz
Nephrology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario La Paz
Nephrology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Ramon Y Cajal
Nephrology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario De Burgos
Dialysis Unit, Avenida De Las Islas Baleares 3, 09006, Burgos
Complexo Hospitalario Universitario A Coruna
Nephrology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Germans Trias I Pujol
Nephrology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Doctor Peset
Nephrology, Av. de Gaspar Aguilar, 90, Valencia
Bellvitge University Hospital
Nephrology, Carrer de la Feixa Llarga, s/n, Barcelona

Sweden

2 sites · Ongoing, recruiting
Region Halland
Nephrology, Lasarettsvagen 1, 302 33, Halmstad
Karolinska University Hospital
Njurmedicin, Halsovagen, Flemingsberg, Huddinge

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2023-08-30 2023-11-02 2025-08-06
Germany 2023-06-20 2023-12-01 2025-08-06
Italy 2022-12-14 2023-03-24
Spain 2023-04-13 2023-07-11
Sweden 2023-04-21 2023-11-20

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 5 · Art. 38 CTR

Temporary halt TH-93471

Halt date
2025-08-06
Member states concerned
Germany
Publication date
2025-08-06
Reason
Medicinal Product related
Explanation
Following the inclusion of a new manufacturing site (Galenica Senese) for the investigational medicinal product XyloCore via Substantial Modification 1, the production schedule has been significantly impacted due to a delay in the supply of the active pharmaceutical ingredient (API) xylitol. As a direct consequence of this unforeseen supply issue, we are required to temporarily halt the clinical trial.
Follow-up measures
Actively working to resume the production of the IMP as soon as possible, with the aim of restarting recruitment in autumn 2025. However, we are currently unable to confirm an exact date.
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-93473

Halt date
2025-08-06
Member states concerned
Italy
Publication date
2025-08-06
Reason
Medicinal Product related
Explanation
Following the inclusion of a new manufacturing site (Galenica Senese) for the investigational medicinal product XyloCore via Substantial Modification 1, the production schedule has been significantly impacted due to a delay in the supply of the active pharmaceutical ingredient (API) xylitol. As a direct consequence of this unforeseen supply issue, we are required to temporarily halt the clinical trial.
Follow-up measures
Actively working to resume the production of the IMP as soon as possible, with the aim of restarting recruitment in autumn 2025. However, we are currently unable to confirm an exact date.
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-93475

Halt date
2025-08-06
Member states concerned
Spain
Publication date
2025-08-06
Reason
Medicinal Product related
Explanation
Following the inclusion of a new manufacturing site (Galenica Senese) for the investigational medicinal product XyloCore via Substantial Modification 1, the production schedule has been significantly impacted due to a delay in the supply of the active pharmaceutical ingredient (API) xylitol. As a direct consequence of this unforeseen supply issue, we are required to temporarily halt the clinical trial.
Follow-up measures
Actively working to resume the production of the IMP as soon as possible, with the aim of restarting recruitment in autumn 2025. However, we are currently unable to confirm an exact date.
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-93477

Halt date
2025-08-06
Member states concerned
Sweden
Publication date
2025-08-06
Reason
Medicinal Product related
Explanation
Following the inclusion of a new manufacturing site (Galenica Senese) for the investigational medicinal product XyloCore via Substantial Modification 1, the production schedule has been significantly impacted due to a delay in the supply of the active pharmaceutical ingredient (API) xylitol. As a direct consequence of this unforeseen supply issue, we are required to temporarily halt the clinical trial.
Follow-up measures
Actively working to resume the production of the IMP as soon as possible, with the aim of restarting recruitment in autumn 2025. However, we are currently unable to confirm an exact date.
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-93469

Halt date
2025-08-06
Member states concerned
Denmark
Publication date
2025-08-06
Reason
Medicinal Product related
Explanation
Following the inclusion of a new manufacturing site (Galenica Senese) for the investigational medicinal product XyloCore via Substantial Modification 1, the production schedule has been significantly impacted due to a delay in the supply of the active pharmaceutical ingredient (API) xylitol. As a direct consequence of this unforeseen supply issue, we are required to temporarily halt the clinical trial.
Follow-up measures
Actively working to resume the production of the IMP as soon as possible, with the aim of restarting recruitment in autumn 2025. However, we are currently unable to confirm an exact date.
Benefit-risk balance changed
No
Treatment stopped
No

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 135 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_CTD approved Protocol 2024-513562-19-00 3.0
Protocol (for publication) D1_CTD approved Protocol 2024-513562-19-00 SWE 3.0 Sweden
Protocol (for publication) D1_Protocol 2024-513562-19-00 6.0
Protocol (for publication) D1_Protocol 2024-513562-19-00 Summary of Changes 6.0
Protocol (for publication) D1_Protocol 2024-513562-19-00 trackchanges 6.0
Recruitment arrangements (for publication) Not Applicable 1
Recruitment arrangements (for publication) Not Applicable 1
Recruitment arrangements (for publication) Not Applicable 1
Recruitment arrangements (for publication) Not Applicable 1
Recruitment arrangements (for publication) Not Applicable 1
Subject information and informed consent form (for publication) L1_SIS and ICF genetic test_GER 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF genetic test_ITA 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF genetic test_SPA 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF personal data_ITA 2.2
Subject information and informed consent form (for publication) L1_SIS and ICF personal data_SPA 2.1
Subject information and informed consent form (for publication) L1_SIS and ICF_DK 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_GER 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_ITA 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF_SPA 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_SWE 3.0
Subject information and informed consent form (for publication) L2_ Other subject information material_GP letter_DEN 2.0
Subject information and informed consent form (for publication) L2_ Other subject information material_GP letter_GER 2.0
Subject information and informed consent form (for publication) L2_ Other subject information material_GP letter_ITA 2.0
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet monocompartimental_GER 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet monocompartimental_ITA 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet monocompartimental_SPA 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet monocompartimental_SWE 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet_DEN 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet_GER 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet_ITA 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet_SPA 1
Subject information and informed consent form (for publication) L2_ Other subject information material_leaflet_SWE 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Patient card_DEN 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Patient card_GER 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Patient card_ITA 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Patient card_SPA 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Patient card_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_high calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_high calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_high calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_low calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_low calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_low calcium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_low calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance high glucose_low calcium_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_high calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_high calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_high calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_low calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_low calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_low calcium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_low calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance low glucose_low calcium_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_high calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_high calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_high calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_low calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_low calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_low calcium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_low calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Balance medium glucose_low calcium_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_high calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_high calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_high calcium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_high calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_high calcium_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_low calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_low calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera high glucose_low calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_high calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_high calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_high calcium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_high calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_high calcium_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_low calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_low calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera low glucose_low calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_high calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_high calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_high calcium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_high calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_high calcium_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_low calcium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_low calcium_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Bicavera medium glucose_low calcium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal all strenghts_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal all strenghts_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal all strenghts_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal all strenghts_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal all strenghts_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal all strenghts_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal low_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Dianeal medium_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Equibalance high glucose_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Equibalance low glucose_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Equibalance medium glucose_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Fixioneal 35 high_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Fixioneal 35 low_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Fixioneal 35 medium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35 high_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35 low_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35 medium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35 medium_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 35_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40 high_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40 low_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40 medium_DK 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_GER 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_ITA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_SPA 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_SWE 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Physioneal 40_SWE 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_DAN 2024-513562-19-00 5.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2024-513562-19-00 5.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_GER 2024-513562-19-00 5.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_ITA 2024-513562-19-00 5.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_SPA 2024-513562-19-00 5.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_SWE 2024-513562-19-00 5.0

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-05-30 Germany Acceptable
2024-07-02
 2024-07-03
2 SUBSTANTIAL MODIFICATION SM-1 2024-12-03 Germany Acceptable
2025-03-13
 2025-03-13
3 SUBSTANTIAL MODIFICATION SM-4 2025-03-28 Acceptable 2025-05-19
4 SUBSTANTIAL MODIFICATION SM-5 2025-11-27 Acceptable 2026-02-24
5 SUBSTANTIAL MODIFICATION SM-6 2026-01-26 Acceptable 2026-03-05
6 SUBSTANTIAL MODIFICATION SM-7 2026-03-10 Germany Acceptable
2026-05-29
 2026-05-29

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