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