Efficiency of L-Carnitine-containing Peritoneal Dialysis Solutions for diurnal exchanges in diabetes type 2 CAPD patients with ESRD on glucose metabolism. Randomized, parallel study compared versus a Standard Glucose Solution (1.5 or 2.5%) - ND
- Conditions
- Patients affected by End Stage Renal Disease (ESRD) treated with Continuous Ambulatory Peritoneal Dialysis (CAPD)MedDRA version: 9.1Level: LLTClassification code 10038444Term: Renal failure chronic
- Registration Number
- EUCTR2006-005300-13-IT
- Lead Sponsor
- IPERBOREAL PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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 < 8.5%
3.Be in treatment with androgens
4.Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method