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
  Purpose

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.


Condition Intervention
Kidney Transplantation
Drug: cimetidine arrow

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • comparison between inulin clearance and cystatin C [ Time Frame: two days ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
patients who received cimétidine
Drug: cimetidine arrow
patients who received cimétidine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00475059

Locations
France
Nephrology unit, CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Christophe Mariat, MD PhD CHU-Saint-Etienne
  More Information

Publications:

Responsible Party: Clément CAILLAUX, Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00475059     History of Changes
Other Study ID Numbers: 0608090, 2006-005294-22
Study First Received: May 16, 2007
Last Updated: January 5, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
kidney transplantation
Glomerular filtration rate
inulin clearance
MDRD equation
cystatin C
cimetidine

Additional relevant MeSH terms:
Cimetidine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014