L-Carnitine in Peritoneal Dialysis

NCT ID: NCT00922701

Last Updated: 2010-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2004-12-31

Brief Summary

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.

Conditions

End-Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peritoneal Dialysis Solution

Group Type: EXPERIMENTAL

L-carnitine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iperboreal Pharma Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Iperboreal Pharma Srl

Principal Investigators

Mario Bonomini, M.D.

Role: PRINCIPAL_INVESTIGATOR

G. d'Annunzio University

Arduino Arduini, M.D.

Role: STUDY_DIRECTOR

Iperboreal Pharma Srl

Locations

Division of Nephrology, University of "G. d'Annunzio"

Chieti, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 21525850 (View on PubMed)

Other Identifiers

IP-001-04

Identifier Type: -

Identifier Source: org_study_id