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

Iperboreal Pharma

Status and phase

Completed

Phase 2

Conditions

End-Stage Renal Disease

Treatments

Drug: L-Carnitine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00851838

IP-001-06

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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