E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with ESRD treated by CAPD |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038444 |
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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 |
1. To assess the safety and tolerability of the experimental solutions by: • recording the incidence and severity of adverse events; • recording a subjective questionnaire on the patient’s perception of well being; • monitoring the changes in routine blood biochemical and hematological parameters |
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E.2.2 | Secondary objectives of the trial |
1. To assess the effects of experimental solutions • peritoneal clearances; • peritoneal transport characteristics with respect to Day 0 and the follow-up period 2. To assess the effects of experimental solutions on peritoneum functionality by evaluation of changes in CA 125 and protein levels in ultrafiltrate |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For inclusion in the study, patients of both genders must fulfill the following criteria, verified during the screening period: 1. Age ≥18 years; 2. Diagnosis of ESRD treated for at least three month with CAPD, as stated by the medical staff of the center; 3. Stable clinical condition within four weeks before screening period, certified by medical/surgical history, physical examination and laboratory exploration; 4. Hemoglobin level ≥9g/dL; 5. Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection; 6. To understand and sign an informed consent form. For patients who will be included in Group B, the following criteria must be fulfilled too: 7. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month 8. Be treated with 1; 2 or 3 diurnal exchange bag solutions (solution bags with 1,5% glucose) and one nocturnal exchange bag solution with icodextrin (Extraneal). |
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E.4 | Principal exclusion criteria |
Patients who fulfill one or more of the following criteria will not be enrolled in the study: 1. History of alcohol or drug abuse in the last six months before selection for the study; 2. Androgen therapy in the last six months before selection; 3. Active infections; 4. History of congestive heart failure stage III and IV NYHA; 5. History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection; 6. Clinically relevant cardiac arrhythmia; 7. Clinically relevant abnormalities of functional hepatic tests; 8. Therapy with L-carnitine or its derivatives in the last three months before selection; 9. Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception; 10. Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with assessment of study parameters, especially if the life expectation is less then one year; 11. Participation in another clinical study within the past month; 12. Known allergic reactions to L-carnitine or xylitol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
recording the incidence and severity of adverse events; recording a subjective questionnaire on the patient’s perception of well being; monitoring the changes in routine blood biochemical and hematological parameters |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
soluzioni standard x D.P. scambi notturno e diurni |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | No |
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 | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |