A Study of Glucothera Plus for Peritoneal Dialysis in Children (ASTRA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Iperboreal Pharma S.r.l.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Diseases [C] - Male Urogenital Diseases [C12]

Trial duration

29 Apr 2024 → ongoing

Decision date (initial)

2024-04-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-512078-88-00

EudraCT number

2022-002684-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Demonstrate the safety of Glucothera Plus in the pediatric population

Secondary objectives 1

1. Assess efficacy parameters, including restoration of L-carnitine levels

Conditions and MedDRA coding

End-stage Kidney Disease

Study design 3 periods

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003049-PIP01-21

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male and female patients younger than 18 years old
2. Diagnosed with ESRD and in treatment with CAPD or APD for the last 6 months
3. L-carnitine plasma level ≤30 nmol/ml
4. Dwell volume from 800 ml/m2 to 1200 ml/m2 body surface
5. Have not experienced peritonitis episodes in the last 3 months
6. Provided written informed consent to participate in the study

Exclusion criteria 14

1. Male and female patients ≥ 18 years old
2. Subjects with reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adesions
3. Uncontrolled hyperphosphatemia
4. Participation in a clinical trial with an investigational drug within one month prior start of study. Prior participation in this trial
5. Suspicion of drug abuse
6. Severe pulmonary, cardiac or hepatic disease/insufficiency
7. Clinically significant abnormal liver function test (Gamma-GT > 4 times the upper normal limit and/or transaminases (AST and/or ALT) > 3 upper normal limits)
8. Any kind of malignancy
9. Lack of appropriate caregiver support
10. Impeding/major abdominal surgery
11. Enrolment in another clinical trial involving medical or device based interventions during a) the 30 days before the screening or b) 5-times the halflife of the used investigational product (the longest period should be considered).
12. Ipersensibility to Glucose, L-Carnitine and other Glucothera Plus components
13. Evidence of any condition that, according to the investigators’ judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially affecting the study quality data.
14. Female patients who are pregnant or breast-feeding or women of childbearing potential* not receiving adequate contraceptive methods

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Safety assesses on the basis of continuous Adverse Events reporting, including evaluation of blood pressure and weight

Secondary endpoints 7

1. Kt/V urea (V2 and V3)
2. 24h Peritoneal ultrafiltration (V2 and V3)
3. 24h urinary volume (V2 and V3)
4. Peritoneal Equilibration Test (V2 and V3)
5. Residual Kidney Function (V2 and V3)
6. Plasma L-carnitine (V1, V2 and V3)
7. Tolerability assessment - blood chemistry and hematology (V2, V3, V4)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Iperboreal Pharma S.r.l.

Sponsor organisation

Iperboreal Pharma S.r.l.

Address

Via L'Aquila 9

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 3

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

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

Temporary halts 1 · Art. 38 CTR

Application history

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