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

Phase 2

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Drug: L-Carnitine

• Registration Number: NCT00851838
• Lead Sponsor: Iperboreal Pharma Srl

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-25
• Study First Submitted QC: 2009-02-25
• Study First Posted: 2009-02-26
• Study Start: 2009-06
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2019-06-24
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD solution	L-Carnitine	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of L-Carnitine containing PD solution on peritoneal ultrafiltration	day 5

Trial Locations

Locations (1)

Division of Nephrology, University of "G. d'Annunzio"; 🇮🇹 Chieti, Italy