E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Utilization of a peritoneal solution containing L-Carnitine as osmotic agent in the treatment of ESRD patients with APD |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038444 |
|
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 |
Efficacy and tolerability of a peritoneal dialysis solution for notturnal exchange containing L-Carnitine in End Stage Renal Disease Patients (ESRD) in Automatised Peritoneal Dialysis (APD) |
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E.2.2 | Secondary objectives of the trial |
1. weekly Kt/V 2. weekly plasmatic Creatinine Clearance(CrCL) 3. PET Creatinine 4. PET Glucose 5. Diuresis 6. ultrafiltration (UF) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Age equal/more 18 years 2. Diagnosis of ESRD treated with nocturnal exchange in APD (glucose 1.36 or 2.27%) from at least 1 month 3. Stable clinical condition in the 4 weeks before the Screening Period evaluated by medical history, physical examination, laboratory parameters of renal function and peritoneal permeability 4. Hemoglobin more 8,5 g/100ml 5. No peritonitis in the previous 3 months 6. To be treated in the experimental site from at least 3 months 7. Signed Informed Consent |
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E.4 | Principal exclusion criteria |
1.Have a history of drug or alcohol abuse in the six months prior to entering the protocol 2.Treatment with androgens 3.Diabetes Mellitus (according to ADA criteria, documented by a fasting glucose and HbA1c) 4.Clinically significant abnormal liver function test (SGOT/SGPT and gammaGT more than 2 times upper normal limit) 5.Presence of infectious conditions 6.Have a history of congestive heart failure and clinically significant arrhythmia 7.History of epilepsy or any NCS disease 8.Have malignancy within the past 5 years, including lymphoproliferative disorders 9.Have any medical condition that, in the judgment of the Investigator, would jeopardize the patients safety following exposure to study drug 10.Have a history of L-Carnitine therapy 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) |
Efficacy and tolerability of a peritoneal dialysis solution for notturnal exchange containing L-Carnitine in End Stage Renal Disease Patients (ESRD) in Automatised Peritoneal Dialysis (APD) |
|
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
aperto, ogni soggetto e' controllo di se stesso |
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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 |
ogni soggetto e' controllo di se stesso |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |