E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients affected by End Stage Renal Disease (ESRD) treated with Continuous Ambulatory Peritoneal Dialysis (CAPD) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038444 |
E.1.2 | Term | Renal failure chronic |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
|
E.4 | Principal 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 < 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メ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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Soluzione standard per dialisi peritoneale |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |