L-Carnitine as an Osmo-metabolic Agent for Peritoneal Dialysis

Study Overview
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Brief Summary
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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 L-carnitine as an osmotic agent to partially replace glucose.

Official Title
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Phase 2 Study of Dialysis Efficiency and Tolerability of Peritoneal Dialysis Solution Containing Glucose Plus L-Carnitine in APD (Automated Peritoneal Dialysis) Treated Uremic Patients

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Drug: L-Carnitine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Have a diagnosis of ESRD and have been on Automated Peritoneal Dialysis (glucose 1.5 or 2.5 % w/v) for at least 3 months Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators) Have not experienced peritonitis episodes in the last 3 months Have Kt/V urea measurement > 1.7 per week in a previous test performed within 6 months that should be confirmed at Baseline Visit Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit Be treated by the participating clinical Investigator for a period of at least three months Have understood and signed the Informed Consent Form. Exclusion Criteria: Have a history of drug or alcohol abuse in the six months prior to entering the protocol Be in treatment with androgens Have Diabetes Mellitus (as defined by the American Diabetes Society, objectively documented by a fasting plasma glucose and HbA1c determinations) Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit) Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc) Have a history of congestive heart failure and clinically significant arrhythmia Have an history of epilepsy or any NCS disease Have malignancy within the past 5 years, including lymphoproliferative disorders Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year Have a history of L-Carnitine therapy or use in the month prior to entering the protocol Have used any investigational drug in the 3 months prior to entering the protocol Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD solution<br> | Drug: L-Carnitine<br>* Instillation of glucose-based (1.5 or 2.5 w/v) PD solution containing L-carnitine during the nocturnal exchange in APD treated patients. L-Carnitine (0.1% w/v) is present only in the first 5 Liter APD bag. PD solutions are instilled for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of L-Carnitine containing PD solution on peritoneal ultrafiltration |  | day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis, L-carnitine, ESRD