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 >=18 years 2.Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months 3.Have Type 2 Diabetes, diagnosed according to American Diabetes Association (fasting glucose >=126 mg/dl and 2 h glucose at OGTT >=200 mg/dl), and treated with multiple daily insulin injection or with HbA1c >=8.5% 4.Be in a stable clinical condition during the 4 weeks immediately prior to Run-In Period as demonstrated by medical history, physical examination and laboratory testing 5.Have a blood hemoglobin concentration > 8,5 g/100ml 6.Have not experienced peritonitis episodes in the last 3 months 7.Be treated with nocturnal exchange bag solution with ecodestrine (Extraneal) for at least 1 month 8.Be treated with 2 or 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal) 9.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 Run-In Period 10.Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 3 months that should be confirmed at Day 0 of Run-In Period 11.Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 3 months that should be confirmed at Day 0 of Run-In Period 12.Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 3 months that should be confirmed at Day 0 of Run-In Period 13.Be treated by the participating clinical Investigator for a period of at least three months 14.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: 1.Have a history of drug or alcohol abuse in the 6 months prior to entering the protocol 2.Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C 2 times the upper normal limit) 5.Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc) 6.Have a history of severe congestive heart failure and clinically significant arrhythmia 7.Have an history of epilepsy or any NCS disease 8.Have malignancy within the past 5 years, including lymphoproliferative disorders 9.Have any chronic medical condition that, in the judgment of the Investigator, would jeopardize the patient?s safety following exposure to study drug 10.Have a history of L-Carnitine (and derivates) treatment or use in the month prior to entering the protocol 11.Have used any investigational drug in the 3 months prior to entering the protocol 12.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 insulin requirement monitoring;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 containg 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 insulin requirement monitoring | — |
Countries
Italy
Outcome results
None listed