Patients affected by End stage renal disease ESRD treated with Continuous Ambulatory Peritoneal Dialysis CAPD . MedDRA version: 9.1 Level: LLT Classification code 10038444 Term: Renal failure chronic
Conditions
Interventions
Product Name: L-carnitine glucose solution 1.5
Product Code: IP015
Pharmaceutical Form: Solution for peritoneal dialysis
Current Sponsor code: IP015
Concentration unit: g gram(s)
Concentration type
Sponsors
IPERBOREAL PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 8805;18 years 2.Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis CAPD for at least 3 months 3.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 4.Have a blood hemoglobin concentration 8,5 g/100ml 5.Have not experienced peritonitis episodes in the last 3 months 6.be treated with nocturnal exchange bag solution with icodesctrine Extraneal for at least 1 month 7.Be treated with 2 or 3 diurnal exchange bag solutions 1.5 or 2.5 glucose and one nocturnal exchange bag solution with icodestrine Extraneal 8.Have Kt/V urea measurement 1.7 per week in a previous test performed within 6 months that should be confirmed at Day 0 of Screening Period 9.Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Day 0 of Screening Period 10.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 Day 0 of Screening Period 11.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 Day 0 of Screening Period 12.Be treated by the participating clinical Investigator for a period of at least three months 13.Have understood and signed the Informed Consent Form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Have a history of drug or alcohol abuse in the 6 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 glucose and HbA1c 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 chronic medical condition that, in the judgment of the Investigator, would jeopardize the patient s safety following exposure to study drug Have a history of L-Carnitine or derivates treatment 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 |
|---|---|
| Main Objective: To assess the efficacy of L-Carnitine containing PD solution versus a standard glucose solution 1.5 or 2.5 on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp.;Secondary Objective: 1 To assess the efficacy of L-Carnitine containing PD solution on triglycerides, cholesterol and lipoprotein profile 2 To assess the efficacy of L-Carnitine containing PD solution on hematological parameters hemoglobin 3 To assess the efficacy of L-Carnitine containing PD solution on concomitant erythropoietin treatment regimen;Primary end point(s): To assess the efficacy of L-Carnitine containing PD solution versus a standard glucose solution 1.5 or 2.5 on insulin sensitivity evaluated by euglycemic hyperinsulinemic clamp | — |
Countries
Italy
Outcome results
None listed