Estimating glomerular filtration rate in kidney transplantation: a comparison between inulin clearance and MDRD equation with cimetidin (block of secretion renal tubule) MedDRA version: 8.1 Level: PT Classification code 10018355 Term: Glomerular filtration rate
Conditions
Interventions
Trade Name: Cimetidine arrow
Pharmaceutical Form: Tablet
Sponsors
CHU Saint-Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: compare performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidin, in kidney transplantation;Secondary Objective: ? 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 ;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. | — |
Countries
France
Outcome results
None listed