Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-03-15 @ 7:50 AM
Study NCT ID:
NCT00475059
Status:
COMPLETED
Last Update Posted:
2010-01-06
First Post:
2007-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-05', 'studyFirstSubmitDate': '2007-05-16', 'studyFirstSubmitQcDate': '2007-05-16', 'lastUpdatePostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'performance of inulin clearance and MDRD with or no block of secretion renal tubule with cimetidine', 'timeFrame': 'two days'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': 'two days'}, {'measure': 'comparison between inulin clearance and cystatin C', 'timeFrame': 'two days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['kidney transplantation', 'Glomerular filtration rate', 'inulin clearance', 'MDRD equation', 'cystatin C', 'cimetidine'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '1244564', 'type': 'BACKGROUND', 'citation': 'Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.'}, {'pmid': '16212629', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1600-6143.2005.01070.x.'}, {'pmid': '14675062', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1523-1755.2004.00350.x.'}, {'pmid': '15476483', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1600-6143.2004.00579.x.'}, {'pmid': '16095498', 'type': 'BACKGROUND', 'citation': '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': '15888034', 'type': 'BACKGROUND', 'citation': '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': '16433763', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1600-6143.2005.01140.x.'}, {'pmid': '11907426', 'type': 'BACKGROUND', '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. doi: 10.1097/00007890-200203150-00020.'}, {'pmid': '7604438', 'type': 'BACKGROUND', 'citation': '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': '2645534', 'type': 'BACKGROUND', '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. doi: 10.1159/000185340. No abstract available.'}, {'pmid': '9296320', 'type': 'BACKGROUND', '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. doi: 10.1046/j.1365-2125.1997.t01-1-00567.x.'}, {'pmid': '15888019', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1600-6143.2005.00939.x. No abstract available.'}, {'pmid': '11904577', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '15659562', 'type': 'BACKGROUND', '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. doi: 10.1681/ASN.2004070549. Epub 2005 Jan 19.'}, {'pmid': '15615823', 'type': 'BACKGROUND', '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. doi: 10.1681/ASN.2004060447. Epub 2004 Dec 22.'}, {'pmid': '16236805', 'type': 'BACKGROUND', '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. doi: 10.1681/ASN.2005050512. Epub 2005 Oct 19.'}, {'pmid': '15698457', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1523-1755.2005.00182.x.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBlocking the tubular secretion of creatinine with an oral administration of cimetidine is likely to make creatinine a more accurate marker of GFR.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplantation \\> 1 year\n* Patient with immunosuppressant treatment of TACROLIMUS (PROGRAF)\n* Creatinine clearance \\> 30 ml/min/1,73m2 within 3 months before inclusion\n* Written informed consent\n* Patient affiliated to social insurance\n\nExclusion Criteria:\n\n* Unstable renal function defined by serum creatinine (J0) \\> 25% serum creatinine realised in 3 months\n* Treatment: Bactrim, Fansidar, Cimetidine arrow within the week before inclusion\n* Contraindication listed in the labeling of Cimetidine arrow\n* Last residual rate of Tacrolimus \\> 12 ng/ml.\n* Treatment : carvedilol, phenytoïn (interaction with cimetidine)\n* Serious hepatic insufficiency'}, 'identificationModule': {'nctId': 'NCT00475059', 'briefTitle': 'Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Performance of Cimetidine-corrected MDRD Equation in Renal Transplant Patients', 'orgStudyIdInfo': {'id': '0608090'}, 'secondaryIdInfos': [{'id': '2006-005294-22'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patients who received cimétidine', 'interventionNames': ['Drug: cimetidine arrow']}], 'interventions': [{'name': 'cimetidine arrow', 'type': 'DRUG', 'description': 'patients who received cimétidine', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Nephrology unit, CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Christophe Mariat, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Clément CAILLAUX', 'oldOrganization': 'Centre Hospitalier Universitaire de Saint Etienne'}}}}