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Performance of Cimetidine-Corrected MDRD Equation in Renal Transplant Patients
This study has been completed.
Study NCT00475059   Information provided by Centre Hospitalier Universitaire de Saint Etienne
First Received: May 16, 2007   Last Updated: June 4, 2008   History of Changes

May 16, 2007
June 4, 2008
March 2007
March 2007   (final data collection date for primary outcome measure)
performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine [ Time Frame: two days ]
Same as current
Complete list of historical versions of study NCT00475059 on ClinicalTrials.gov Archive Site
  • 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 ]
  • comparison between inulin clearance and cystatin C [ Time Frame: two days ]
Same as current
 
Performance of Cimetidine-Corrected MDRD Equation in Renal Transplant Patients
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.

 
 
Interventional
Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Kidney Transplantation
Drug: cimetidine arrow
Experimental: patients who received cimétidine

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
60
March 2008
March 2007   (final data collection date for primary outcome measure)

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

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00475059
Dr Mariat Christophe, Centre Hospitalier Universitaire de Saint Etienne
0608090, 2006-005294-22
Centre Hospitalier Universitaire de Saint Etienne
 
Principal Investigator: Christophe Mariat, MD PhD CHU-Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP