E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult liver transplanted patients age > 18 years , with pre-transplantation normal renal function creatinine clearance 1ml/kg/min |
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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 | LLT |
E.1.2 | Classification code | 10038436 |
E.1.2 | Term | Renal failure acute |
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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 evaluate, in patients with early renal dysfunction after liver transplantation, the efficacy of fenoldopam mesylate in preserving/improving renal function glomerular filtration rate . |
|
E.2.2 | Secondary objectives of the trial |
to evaluate if cystatin-C can be a reliable marker of glomerular filtration GFR changes in critically ill patient to evaluate if cystatin-C level may detect the changes in renal function due to vasoactive drugs as fenoldopam |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
adult liver transplanted patients age > 18 years , with pre-transplantation normal renal function creatinine clearance > 1ml/kg/min , characterized in the first week after liver transplantation by increase of serum creatinine more than 1,5 times compared to pre-operative value or urine out-put reduction 0,5 ml/kg/h for over 6 hours period without loop diuretics administration and after cardiovascular performance optimization hemodynamic stability defined as stable values of systemic systolic blood pressure 100 mmHg over the 6-hr period immediately preceding the enrollment low doses of vasopressor drugs are allowed . |
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E.4 | Principal exclusion criteria |
life expectancy > 48 hrs renal dysfunction requiring renal replacement therapies hemodynamic instability sepsis urgent surgery need during the study administration of loop diuretic drugs furosemide 250 mg/24 hrs |
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E.5 End points |
E.5.1 | Primary end point(s) |
to evaluate, in patients with early renal dysfunction after liver transplantation, the efficacy of fenoldopam mesylate in preserving/improving renal function glomerular filtration rate . |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 |