Performance of Cimetidine-Corrected MDRD Equation in Renal Transplant Patients
Information source: Centre Hospitalier Universitaire de Saint Etienne
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Transplantation
Intervention: cimetidine arrow (Drug)
Sponsored by: Centre Hospitalier Universitaire de Saint Etienne
Official(s) and/or principal investigator(s):
Christophe Mariat, MD PhD, Principal Investigator, Affiliation: CHU-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
Official title: Performance of Cimetidine-Corrected MDRD Equation in Renal Transplant Patients
Study design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine
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
comparison between inulin clearance and cystatin C
Minimum age: 18 Years.
Maximum age: N/A.
- > 18 years
- 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
- 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
Locations and Contacts
Nephrology unit, CHU Saint-Etienne, Saint-Etienne 42055, France
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.
Starting date: March 2007
Ending date: March 2008
Last updated: June 4, 2008