Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Not Applicable

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: cimetidine arrow

• Registration Number: NCT00475059
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-17
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-05
• Last Update Posted: 2010-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	cimetidine arrow	patients who received cimétidine

Primary Outcome Measures

Name	Time	Method
performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine	two days

Secondary Outcome Measures

Name	Time	Method
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	two days
comparison between inulin clearance and cystatin C	two days

Trial Locations

Locations (1)

Nephrology unit, CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France