Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

NCT00475059 | Completed

• 2 other identifiers: 06080902006-005294-22
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplantation

Keywords

kidney transplantation; Glomerular filtration rate; inulin clearance; MDRD equation; cystatin C; cimetidine

Outcome Measures

Primary Outcomes (1)

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

  two days

Secondary Outcomes (2)

• 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

  two days

• comparison between inulin clearance and cystatin C

  two days

Study Arms (1)

1

EXPERIMENTAL

patients who received cimétidine

Drug: cimetidine arrow

Interventions

cimetidine arrow DRUG

patients who received cimétidine

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplantation \> 1 year
• Patient with immunosuppressant treatment of TACROLIMUS (PROGRAF)
• Written informed consent
• Patient affiliated to social insurance

You may not qualify if:

• Unstable renal function defined by serum creatinine (J0) \> 25% serum creatinine realised in 3 months
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Nephrology unit, CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (17)

• Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

  PMID: 1244564 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2005.01070.x.

  PMID: 16212629 BACKGROUND

• 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. doi: 10.1111/j.1523-1755.2004.00350.x.

  PMID: 14675062 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2004.00579.x.

  PMID: 15476483 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2005.00982.x.

  PMID: 16095498 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2005.00861.x.

  PMID: 15888034 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2005.01140.x.

  PMID: 16433763 BACKGROUND

• 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. doi: 10.1097/00007890-200203150-00020.

  PMID: 11907426 BACKGROUND

• Nankivell BJ, Gruenewald SM, Allen RD, Chapman JR. Predicting glomerular filtration rate after kidney transplantation. Transplantation. 1995 Jun 27;59(12):1683-9. doi: 10.1097/00007890-199506270-00007.

  PMID: 7604438 BACKGROUND

• 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. doi: 10.1159/000185340. No abstract available.

  PMID: 2645534 BACKGROUND

• 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. doi: 10.1046/j.1365-2125.1997.t01-1-00567.x.

  PMID: 9296320 BACKGROUND

• 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. doi: 10.1111/j.1600-6143.2005.00939.x. No abstract available.

  PMID: 15888019 BACKGROUND

• 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.

  PMID: 11904577 BACKGROUND

• 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. doi: 10.1681/ASN.2004070549. Epub 2005 Jan 19.

  PMID: 15659562 BACKGROUND

• 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. doi: 10.1681/ASN.2004060447. Epub 2004 Dec 22.

  PMID: 15615823 BACKGROUND

• 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. doi: 10.1681/ASN.2005050512. Epub 2005 Oct 19.

  PMID: 16236805 BACKGROUND

• 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. doi: 10.1111/j.1523-1755.2005.00182.x.

  PMID: 15698457 BACKGROUND

Study Officials

• Christophe Mariat, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 6, 2010

Record last verified: 2010-01

Locations

FR (1)