Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients
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...
Brief Summary
Official Title: “Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients”
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.
- Study Type: Interventional
- Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: cimetidine arrow
- patients who received cimétidine
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- patients who received cimétidine
Outcome Measures for this Clinical Trial
Primary Measures
- performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine
- Time Frame: two days
Safety Issue?: No
- Time Frame: two days
Secondary Measures
- 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
- Time Frame: two days
Safety Issue?: No
- Time Frame: two days
- comparison between inulin clearance and cystatin C
- Time Frame: two days
Safety Issue?: No
- Time Frame: two days
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Centre Hospitalier Universitaire de Saint Etienne Other
Overall Clinical Trial Officials and Contacts
Christophe Mariat, MD PhD Principal Investigator CHU-Saint-Etienne
Related Publications
References
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Mariat C, Alamartine E, Barthelemy JC, De Filippis JP, Thibaudin D, Berthoux P, Laurent B, Thibaudin L, Berthoux F. Assessing renal graft function in clinical trials: can tests predicting glomerular filtration rate substitute for a reference method? Kidney Int. 2004 Jan;65(1):289-97.
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Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00475059
Study ID Number: 0608090
ClinicalTrials.gov Identifier: NCT00475059
Health Authority: France: Afssaps - French Health Products Safety Agency
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