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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iperboreal Pharma Srl

Criteria

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