Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

January 5, 2010 updated by: Centre Hospitalier Universitaire de Saint Etienne

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Nephrology unit, CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
patients who received cimétidine
Drug: cimetidine arrow
patients who received cimétidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine
Time Frame: two days
two days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
two days
comparison between inulin clearance and cystatin C
Time Frame: two days
two days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Christophe Mariat, MD PhD, CHU-Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0608090
  • 2006-005294-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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