Clinical trial NCT00475059: Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients
Official title: Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Keywords: kidney transplantation
Glomerular filtration rate
inulin clearance
MDRD equation
cystatin C
cimetidine
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2007-05-17
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Among the different creatinine-based GFR predicting equations, the MDRD equation gives the best prediction in renal transplantation but does not provide the level of accuracy usually seen in renal patients with native kidneys.

Blocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR.

We will test the hypothesis that the accuracy of the MDRD equation will be improved in renal transplant patients by incorporating into the equation a cimetidine-corrected serum creatinine value.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Unstable renal function defined by serum creatinine (J0) \> 25% serum creatinine realised in 3 months
* Treatment: Bactrim, Fansidar, Cimetidine arrow within the week before inclusion
* Contraindication listed in the labeling of Cimetidine arrow
* Last residual rate of Tacrolimus \> 12 ng/ml.
* Treatment : carvedilol, phenytoïn (interaction with cimetidine)
* Serious hepatic insufficiency

Primary outcomes:
measure: performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine
timeFrame: two days
Secondary outcomes:
measure: Performance of different prediction equations for estimating renal function with or no block of secretion renal tubule with cimetidine : - Walser equation - Nankivell equation - Cockcroft and Gault equation
timeFrame: two days
measure: comparison between inulin clearance and cystatin C
timeFrame: two days
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Nephrology unit, CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Christophe Mariat, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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