Study of Safety and Efficacy on New Peritoneal Dialysis Solutions

Evaluation of a New Peritoneal Dialysis Solutions Containing Glucose, Xylitol and L-carnitine Compared to Standard PD Solutions in End-stage Renal Disease (ESRD) Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

A major challenge of peritoneal dialysis (PD) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (UF) profile. Study hypothesis is to evaluate the possibility to formulate PD solutions containing xylitol and L-carnitine as osmotic agents to partially replace glucose.

Study Overview

• Status: Withdrawn
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Drug: PD solution for nocturnal exchanges; Drug: PD solution for diurnal exchanges

• Study Type: Interventional
• Phase: Phase 2

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:

• Age ≥18 years;
• Diagnosis of ESRD treated for at least three month with CAPD, as stated by the medical staff of the center;
• CAPD treatment with 2.27% of glucose solution for the nocturnal exchange;
• Stable clinical condition within four weeks before screening period, certified by medical/surgical history, physical examination and laboratory exploration;
• Hemoglobin level ≥9g/dL;
• Residual diuresis ≤800mL;
• Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection;
• Stable peritoneal permeability, as confirmed by a PET between 0.50 and 0.81 during previous three months and at day 0 of the screening period;
• Total urea Kt/V >1.5 per week at a control during previous three months and at day 0 of the screening period and/or minimal total creatinine clearance of 45 liter/week at a control during previous three months and at day 0 of the screening period; 1- To understand and sign an informed consent form.

For patients who will be included in Group B, the following criteria must be fulfilled too:

• Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month
• Be treated with 2 or 3 diurnal exchange bag solutions (solution bags with 1.36% or 2.27% glucose) and one nocturnal exchange bag solution (Extraneal)

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 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 assessment of study parameters, especially if the life expectation is less then one year;
• Participation in another clinical study within the past month;
• Known or supposed allergic reactions to L-carnitine or xylitol.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: PD solution for nocturnal exchanges; Instillation of a PD solution containing xylitol (1.5%), L-carnitine (0.1%) and glucose (0.5%) for the nocturnal exchange in CAPD treated patients. PD solutions are instilled for 4 weeks.
Experimental: Group B	Drug: PD solution for diurnal exchanges; Instillation of a PD solution containing xylitol (0.6%), L-carnitine (0.1%) and glucose (0.5%) for the diurnal exchanges in CAPD treated patients. PD solutions are instilled for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess ultrafiltration efficacy of PD solutions containing L-Carnitine and Xylitol	4 weeks

Collaborators and Investigators

• Sponsor: Iperboreal Pharma Srl
• Investigators: Study Director: Cristina Capusa, PhD, "Dr Carol Davila" University Hospital of Nephrology, Romania; Study Chair: Gabriel Mircescu, PhD, "Dr Carol Davila" University Hospital of Nephrology, Romania

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; L-Carnitine; Xylitol
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Pharmaceutical Solutions
• Other Study ID Numbers: IP-001-07

Drug and device information, study documents

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