L-Carnitine in Peritoneal Dialysis

Phase 2 Study of Dialysis Efficiency and Tolerability of Nocturnal Peritoneal Dialysis Solution Containing Glucose Plus L-carnitine

The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy. The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions containing L-carnitine as an osmotic agent to partially replace glucose.

Study Overview

• Status: Completed
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Drug: L-carnitine

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66013
    • Division of Nephrology, University of "G. d'Annunzio"

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
• Have a diagnosis of End Stage Renal Disease and have been on Continuous Ambulatory Peritoneal Dialysis 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
• Be treated with 3 diurnal exchange bag solutions (1.5% or 2.5% glucose) and one nocturnal exchange bag solution (2.5% glucose)
• 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 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 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 central nervous system 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
• Pregnant, lactating, fertility age without protection against pregnancy by adequate contraceptive means

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peritoneal Dialysis Solution	Drug: L-carnitine; Instillation of glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the nocturnal exchange. Patients were treated with the experimental peritoneal dialysis solution for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Dwell Ultrafiltration	The amount of fluid recovered from the peritoneum at the end of the nocturnal exchange (long dwell) with a peritoneal dialysis solution.	day 5

Collaborators and Investigators

• Sponsor: Iperboreal Pharma Srl
• Investigators: Principal Investigator: Mario Bonomini, M.D., G. d'Annunzio University; Study Director: Arduino Arduini, M.D., Iperboreal Pharma Srl

Publications and helpful links

General Publications

• Bonomini M, Pandolfi A, Di Liberato L, Di Silvestre S, Cnops Y, Di Tomo P, D'Arezzo M, Monaco MP, Giardinelli A, Di Pietro N, Devuyst O, Arduini A. L-carnitine is an osmotic agent suitable for peritoneal dialysis. Kidney Int. 2011 Sep;80(6):645-54. doi: 10.1038/ki.2011.117. Epub 2011 Apr 27.

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: February 11, 2009
• First Submitted That Met QC Criteria: April 30, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): February 23, 2010
• Last Update Submitted That Met QC Criteria: February 16, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: L-carnitine; Peritoneal dialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: IP-001-04