Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients - Full Text View

Sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00475059

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:	Control: Uncontrolled 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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cimetidine Cimetidine hydrochloride

U.S. FDA Resources

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
1: Experimental 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

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:

Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41.

Mariat C, Alamartine E, Afiani A, Thibaudin L, Laurent B, Berthoux P, De Filippis JP, Thibaudin D, Mayor B, Elessawy AB, Berthoux F. Predicting glomerular filtration rate in kidney transplantation: are the K/DOQI guidelines applicable? Am J Transplant. 2005 Nov;5(11):2698-703.

Mariat C, Alamartine E, Barthelemy JC, De Filippis JP, Thibaudin D, Berthoux P, Laurent B, Thibaudin L, Berthoux F. Assessing renal graft function in clinical trials: can tests predicting glomerular filtration rate substitute for a reference method? Kidney Int. 2004 Jan;65(1):289-97.

Gaspari F, Ferrari S, Stucchi N, Centemeri E, Carrara F, Pellegrino M, Gherardi G, Gotti E, Segoloni G, Salvadori M, Rigotti P, Valente U, Donati D, Sandrini S, Sparacino V, Remuzzi G, Perico N; MY.S.S. Study Investigators. Performance of different prediction equations for estimating renal function in kidney transplantation. Am J Transplant. 2004 Nov;4(11):1826-35.

Bosma RJ, Doorenbos CR, Stegeman CA, van der Heide JJ, Navis G. Predictive performance of renal function equations in renal transplant recipients: an analysis of patient factors in bias. Am J Transplant. 2005 Sep;5(9):2193-203.

Poge U, Gerhardt T, Palmedo H, Klehr HU, Sauerbruch T, Woitas RP. MDRD equations for estimation of GFR in renal transplant recipients. Am J Transplant. 2005 Jun;5(6):1306-11.

Poggio ED, Wang X, Weinstein DM, Issa N, Dennis VW, Braun WE, Hall PM. Assessing glomerular filtration rate by estimation equations in kidney transplant recipients. Am J Transplant. 2006 Jan;6(1):100-8.

Kemperman FA, Surachno J, Krediet RT, Arisz L. Cimetidine improves prediction of the glomerular filtration rate by the Cockcroft-Gault formula in renal transplant recipients. Transplantation. 2002 Mar 15;73(5):770-4.

Nankivell BJ, Gruenewald SM, Allen RD, Chapman JR. Predicting glomerular filtration rate after kidney transplantation. Transplantation. 1995 Jun 27;59(12):1683-9.

Myara I, Lahiani F, Cosson C, Duboust A, Moatti N. Estimated creatinine clearance by the formula of Gault and Cockcroft in renal transplantation. Nephron. 1989;51(3):426-7. No abstract available.

Goerdt PJ, Heim-Duthoy KL, Macres M, Swan SK. Predictive performance of renal function estimate equations in renal allografts. Br J Clin Pharmacol. 1997 Sep;44(3):261-5.

Perico N, Gaspari F, Remuzzi G. Assessing renal function by GFR prediction equations in kidney transplantation. Am J Transplant. 2005 Jun;5(6):1175-6. No abstract available.

National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

Froissart M, Rossert J, Jacquot C, Paillard M, Houillier P. Predictive performance of the modification of diet in renal disease and Cockcroft-Gault equations for estimating renal function. J Am Soc Nephrol. 2005 Mar;16(3):763-73. Epub 2005 Jan 19.

Poggio ED, Wang X, Greene T, Van Lente F, Hall PM. Performance of the modification of diet in renal disease and Cockcroft-Gault equations in the estimation of GFR in health and in chronic kidney disease. J Am Soc Nephrol. 2005 Feb;16(2):459-66. Epub 2004 Dec 22.

White C, Akbari A, Hussain N, Dinh L, Filler G, Lepage N, Knoll GA. Estimating glomerular filtration rate in kidney transplantation: a comparison between serum creatinine and cystatin C-based methods. J Am Soc Nephrol. 2005 Dec;16(12):3763-70. Epub 2005 Oct 19.

Lemahieu WP, Maes BD, Verbeke K, Vanrenterghem Y. Impact of gastric acid suppressants on cytochrome P450 3A4 and P-glycoprotein: consequences for FK506 assimilation. Kidney Int. 2005 Mar;67(3):1152-60.

Responsible Party:	Centre Hospitalier Universitaire de Saint Etienne ( Clément CAILLAUX )
Study ID Numbers:	0608090, 2006-005294-22
Study First Received:	May 16, 2007
Last Updated:	January 5, 2010
ClinicalTrials.gov Identifier:	NCT00475059 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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:

Neurotransmitter Agents
Histamine Antagonists
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Physiological Effects of Drugs

Gastrointestinal Agents
Histamine Agents
Enzyme Inhibitors
Cimetidine
Histamine H2 Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010