E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Estimating glomerular filtration rate in kidney transplantation: a comparison between inulin clearance and MDRD equation with cimetidin (block of secretion renal tubule) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018355 |
E.1.2 | Term | Glomerular filtration rate |
|
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 |
compare performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidin, in kidney transplantation |
|
E.2.2 | Secondary objectives of the trial |
Performance of different prediction equations for estimating renal function in kidney transplantation with or no block of secretion renal tubule with cimetidin : - Walser equation - Nankivell equation - Cockcroft and Gault equation
comparison between inulin clearance and cystatin C |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- > 18 years - Kidney transplantation > 1 year - Patient with immunosuppressant treatment of TACROLIMUS (PROGRAF) - Creatinine clearance > 30 ml/min/1,73m2 within 3 months before inclusion - Written informed consent - Patient affiliated to social insurance
|
|
E.4 | Principal exclusion criteria |
- Unstable renal fonction defined by serum creatinine (J0) > 25% serum creatinine realised in 3 mois - Treatment: Bactrim®, Fansidar®, Cimetidine arrow® withing the week before inclusion - Contraindication listed in in the labeling of Cimetidine arrow® (absolue, relative et médicaments nécessitant des précautions d’emploi cf ficheVidal en annexe 3) - Last residual rate of Tacrolimus > 12 ng/ml. - Treatment : carvedilol, phenytoïne (intercation with cimetidine) - Serious hepatic insuffisancy
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Performance of different prediction equation : accuracy -30%, ie defined by proportion of patients with a estimation of glomerular filtration glomerular is include in - 30 % et + 30 % of inulin clearance value.
|
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| 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 | 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
|
this study is not an evaluation of the investigational product. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 3 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |