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

End-Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851838
• Other study ID #: IP-001-06
• Status: Completed
• Phase: Phase 2
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Iperboreal Pharma Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• L-Carnitine
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.

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