E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10023438 |
E.1.2 | Term | Kidney transplant |
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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 compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX) |
|
E.2.2 | Secondary objectives of the trial |
• progression of CAN at 12 and 36 months • progression of renal function by mGFR at 36 months after renal TX • progression of renal function estimated by cGFR at each follow-up visit (slope of cGFR throughout the study) • efficacy (biopsy proven acute rejection (BPAR), graft loss or death) by 12, 24 and 36 months • occurrence of treatment failures up to or at 12, 24 and 36 months • time to first diagnosed malignancy • development and magnitude of proteinuria • percentage of patients on and number of antihypertensive and lipid lowering drugs at randomization, 12, 24 and 36 months • lipid profile at 12, 24 and 36 months, at selected centers • safety and tolerability
|
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female above 18 year first or second renal transplant receipients willing and capable of giving written informed consent at randomisation: maintained on a triple immunosuppresive regime completed period 1 without experiencing biopsy proven acute rejection negative pregnancy test and on medically approved birth control metod |
|
E.4 | Principal exclusion criteria |
recipients of multi organ transplants PRA >30% receiving renal transplant from HLA-identical sibling past or present malignancy receipients of ABO incompatible transplants at randomisation: graft loss hemoglobin count <80g/l and/or platelet count <50x109/l and/or white blood cell count < 2.5 x 109/l) spot urinary protein/creatinine ratio >150 mg/mmol requiring dialysis and/or having a cGFR <20ml/min |
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E.5 End points |
E.5.1 | Primary end point(s) |
assessing the difference in renal function evaluated by measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX)and at 36 months development of CAN rejection episodes proteinuria time to first diagnosed malignancy |
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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 | Yes |
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) | 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 | 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 |
current immunosuppresive regimen continuation |
|
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 | Yes |
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 | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |