End-Stage Renal Disease
Conditions
Keywords
Peritoneal dialysis, L-carnitine, ESRD
Brief 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.
Interventions
DRUGL-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.
Sponsors
Iperboreal Pharma Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of L-Carnitine containing PD solution on peritoneal ultrafiltration | day 5 |
Countries
Italy
Outcome results
None listed