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

Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)

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.

Study Overview

• Status: Terminated
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine; Drug: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy
    • Department of Nephrology, University of Chieti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental peritoneal dialysis solution IPX15; 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.	Drug: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine; One bag for nocturnal (long-dwell) exchange.; Other Names: IPX15
Experimental: Experimental peritoneal dialysis solution IPX07; 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.	Drug: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine; One to three, daily (short-dwell) exchanges; Other Names: IPX07

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily ultrafiltration volume	Change from baseline	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peritoneal equilibration test	Change from baseline	28 days
Weekly total urea Kt/V	Change from baseline	28 days
Weekly total creatinine clearance	Change from baseline	28 days
Adverse Events	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.	2 months

Collaborators and Investigators

• Sponsor: Iperboreal Pharma Srl
• Investigators: Principal Investigator: Mario Bonomini, MD, Institute of Nephrology, G. D'annunzio University, Chieti, Italy

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: IP-001-09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No