E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Effect of immunosuppressive medication on renal function following livertransplantation |
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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 | 10024716 |
E.1.2 | Term | Liver transplantation |
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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 |
Change in cratinine clearance measured by creatinine clearence in 24 hours urine collection and serum creatinine between baseline and week 12, week 12 and 14, and baseline and week 24 |
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E.2.2 | Secondary objectives of the trial |
- Changes in mean arterial blood pressure and number and dose of antihypertensive medications used between baseline and week 12 and baseline and week 24
- Tacrolimus pharmacokinetics
- Changes in mean lipid levels (total cholesterol, TG, LDL, HDL), and the number and dose of lipid-lowering medications between baseline and week 12 and week 24
- Subject and graft survival
- Creatinine clearance calculated by BSA corrected Cockcroft and GAult and MDRD
- Biopsy proven treated graft rejection
- Side effects |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Livertransplant recipients at least 18 years of age at least 6 months past last transplantation on a stable calcineurin inhibitor based immunosuppressive regimen capable of understanding the purpose and risk of the study.
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E.4 | Principal exclusion criteria |
Multi-organ transplant recipients Allergy/intollerance to the study drugs Patients with a serum creatinine >200 umol/l Pregnant or breastfeading mother
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in renal function, as measured by: Creatinine clearance, measured by creatinine clearance in a 24 hour urine collection and serum creatinine between: 1) baseline and week 12, 2) week 12 and week 24 and 3) baseline and week 24 Creatinine clearance calculated by BSA adjusted Cockcroft and Gault and MDRD |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
First pase uncontrolled, second phase parrallel group |
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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 |
Standard TDM vs Baysian monitoring |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |