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NCT Number: NCT00475059

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology unit, CHU Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cimetidine arrow

Drug

patients who received cimétidine

Primary outcomes

  1. performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine

    Time frame: two days

Secondary outcomes

  1. 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

  2. comparison between inulin clearance and cystatin C

    Time frame: two days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 17, 2007
Registry last updated
Jan 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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