Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Kidney Transplantation Clinical Trial

Official title:

Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475059
• Other study ID #: 0608090
• Secondary ID: 2006-005294-22
• Status: Completed
• Phase: N/A
• First received: May 16, 2007
• Last updated: January 5, 2010
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: January 2010
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• cimetidine arrow
patients who received cimétidine

Locations

Country	Name	City	State
France	Nephrology unit, CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

References & Publications (17)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Pöge 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine		two days	No
Secondary	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	No
Secondary	comparison between inulin clearance and cystatin C		two days	No