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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine
* Drug: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental peritoneal dialysis solution IPX15<br>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<br>* One bag for nocturnal (long-dwell) exchange.<br>* Other names: IPX15;|
| Experimental: Experimental peritoneal dialysis solution IPX07<br>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<br>* One to three, daily (short-dwell) exchanges<br>* Other names: IPX07;|

What is the study measuring?
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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 |