Pilot Study to Evaluate Safety and Efficacy of PolyCore, a Ternary Combination of Xylitol, L-Carnitine and Polydextrin, to Treat End-Stage Kidney Disease Patients Starting Peritoneal Dialysis (EXCITE)

Overview

Sponsor-declared trial summary

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

Trial duration

17 Feb 2026 → ongoing

Decision date (initial)

2025-06-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Vivisol · Iperboreal Pharma Srl

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective is to evaluate the safety of PolyCore through continuous monitoring of adverse events, vital signs, and laboratory parameters.

Secondary objectives 1

1. The secondary objective is to evaluate the efficacy of PolyCore in maintaining adequate depuration, ultrafiltration, and sodium removal

Conditions and MedDRA coding

End-Stage Kidney Disease

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adults with End-Stage Kidney Disease
2. GFR ≥ 5
3. Patients in treatment with peritoneal dialysis for less than 6 months (at screening visit) and in stable clinical conditions
4. Patients in incremental PD treatment with 1 daily Icodextrin(7.5%)-based solution and 1 daily glucose (up to 1.5%)-based solution, according the IPD regimens allowed by the study (at screening and baseline visits)
5. Understand the nature and characteristics of the study and give informed consent to participate
6. Weekly Kt/V urea ≥ 1.7

Exclusion criteria 16

1. Episode of peritonitis in the last 3 months
2. History of oxalate or lactate abnormalities considered clinically significant by the investigator
3. History or evidence of any other medical, neurological, or psychological condition that, in the clinical judgment of the investigator, would place the subject at undue risk of a significant AE or interfere with study assessments during the course of the tri
4. Enrolled in a clinical trial with an investigational product within 1 month before the start of the study
5. Suspected or history of drug and/or alcohol abuse
6. Severe pulmonary, cardiac, or hepatic disease/insufficiency
7. Clinically significant abnormal liver function tests (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)
8. Any type of active malignancy. Patients with excised basal cell carcinoma of the skin may be included
9. Female patients who are pregnant or breastfeeding, or women of childbearing potential who are not using or are refusing to use an adequate contraceptive program
10. Hypersensitivity to any of the components of the study IMPs
11. History of primary hyperoxaluria
12. Patients with acute renal failure
13. Presence of contraindications to the use of Polydextrin-based peritoneal dialysis solutions: allergy to starch-based polymers, maltose or isomaltose intolerance, glycogen storage disease, pre-existing severe lactic acidosis
14. Patients with loss of peritoneal function or extensive adhesions compromising peritoneal function
15. patients with a history of abdominal surgery in the month preceding commencement of therapy, patients with abdominal fistulae, tumors, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface or intra-abdominal cavit
16. Uncorrectable mechanical defects that prevent effective PD or increase the risk of infection.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 8

1. Adverse Events (during the whole study)
2. Physical Examination (at every visit)
3. Vital Signs and body weight (at every visit)
4. Blood chemistry and hematology (at every visit)
5. 24h diuresis analysis (at every visit)
6. 24h dialysate analysis (at every visit)
7. Weekly Kt/V urea (evaluated at every visit)
8. Residual kidney function (at every visit)

Secondary endpoints 7

1. Post-baseline profile of weekly Kt/V urea (at every visit)
2. Peritoneal ultrafiltration (at every visit and daily by patient diary)
3. Peritoneal and total sodium removal (at every visit)
4. Glycemic and lipidic parameters (at every visit)
5. Peritoneal clearances: creatinine, phosphate, B2-microglobulin, (at every visit)
6. Quality of Life: KDQOL-SF (V2, V4)
7. N° of patients who dropped-out from the study for safety and efficacy reasons

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

Dr. Arduino Arduini

Public contact point

Organisation

Iperboreal Pharma S.r.l.

Contact name

Dr. Arduino Arduini

Third parties 6

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 13 files

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

Application history

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