Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol, and L-Carnitine in CAPD

Phase 2

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Drug: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine; Drug: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine

• Registration Number: NCT04001036
• Lead Sponsor: Iperboreal Pharma Srl

Brief Summary

Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Study Start: 2019-09-01
• Status Verified: 2022-08
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Diagnosis of ESRD treated for at least three months with CAPD, as stated by the medical staff of the center;
• Stable clinical condition within four weeks before the screening period, certified by medical/surgical history, physical examination and laboratory exploration;
• Hemoglobin level ≥ 9g/dL;
• Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
• To understand and sign an informed consent form.

Exclusion Criteria

• History of alcohol or drug abuse in the last six months before selection for the study;
• Androgen therapy in the last six months before selection;
• Active infections;
• History of congestive heart failure stage III and IV New York Heart Association (NYHA);
• History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection;
• Clinically relevant cardiac arrhythmia;
• Clinically relevant abnormalities of functional hepatic tests;
• Therapy with L-carnitine or its derivatives in the last three months before selection;
• Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception;
• Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with the assessment of study parameters, especially if the life expectancy is less then one year;
• Participation in another clinical study within the past month;
• Known allergic reactions to L-carnitine or xylitol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental peritoneal dialysis solution IPX15	1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine	Patients will receive treatment with the experimental solution for nocturnal (long-dwell) exchange. For daily (short-dwell) exchanges, all patients will continue the 1 to 3 bags of glucose peritoneal dialysis solution as for their pre-randomization prescription.
Experimental peritoneal dialysis solution IPX07	0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine	Patients will receive 1 to 3 daily (short-dwell) exchanges with the experimental solution (the number of exchanges will be based on their pre-randomization prescription). All patients will receive icodextrin for nocturnal (long-dwell) exchange.

Primary Outcome Measures

Name	Time	Method
Daily ultrafiltration volume	28 days	Change from baseline

Secondary Outcome Measures

Name	Time	Method
Peritoneal equilibration test	28 days	Change from baseline
Weekly total urea Kt/V	28 days	Change from baseline
Weekly total creatinine clearance	28 days	Change from baseline
Adverse Events	2 months	Information about all adverse events, whether volunteered by the patient, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded and followed as appropriate.

Trial Locations

Locations (1)

Department of Nephrology, University of Chieti; 🇮🇹 Chieti, Italy