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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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