L-Carnitine in Peritoneal Dialysis

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922701
• Other study ID #: IP-001-04
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2009
• Last updated: February 16, 2010
• Start date: June 2004
• Est. completion date: December 2004

Study information

• Verified date: February 2010
• Source: Iperboreal Pharma Srl
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
Italy	Division of Nephrology, University of "G. d'Annunzio"	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
Iperboreal Pharma Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long Dwell Ultrafiltration		day 5	Yes