Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00475059
First received: May 16, 2007
Last updated: January 5, 2010
Last verified: January 2010

May 16, 2007
January 5, 2010
March 2007
March 2008   (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 ] [ Designated as safety issue: No ]
performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine [ Time Frame: two days ]
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 ] [ Designated as safety issue: No ]
  • comparison between inulin clearance and cystatin C [ Time Frame: two days ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Kidney Transplantation
Drug: cimetidine arrow
patients who received cimétidine
Experimental: 1
patients who received cimétidine
Intervention: Drug: cimetidine arrow

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00475059
0608090, 2006-005294-22
No
Clément CAILLAUX, Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Christophe Mariat, MD PhD CHU-Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
January 2010

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