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| autoid | 113 |
| crg_id | CRG030600045 |
| titleoftrial | Etude multicentrique randomisee ouverte, d\'evaluation de l\'efficacite et de la tolerance d\'une bitherapie ciclosporine-prednisone versus mycophenolate mofetil-prednisone douze semaines apres la transplantation renale |
| acronymnoftrial | |
| website | http:// |
| identificationno | 1910 |
| leadprefix | Prof |
| leadsurname | NOEL |
| leadgivennames | Christian |
| leadposition | Head |
| leaddepartment | Nephrology |
| leadorganisation | Regional Hospital of Lille |
| leadaddress | Hopital Calmette, CHRU de Lille. Bd du Pr Leclercq. 59037 Lille cedex (France) |
| leademail | cnoel@chru-lille.fr |
| leadphone | +33 3 20 44 41 42 |
| leadfax | +33 3 20 44 41 25 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | HAZZAN |
| contactgivennames | Marc |
| contactposition | |
| contactdepartment | Nephrology |
| contactorganisation | Regional Hospital of Lille |
| contactaddress | Hopital Calmette, CHRU de Lille. Bd du Pr Leclercq. 59037 Lille cedex (France) |
| contactemail | m-hazzan@chru-lille.fr |
| contactphone | +33 3 20 44 58 72 |
| contactfax | +33 3 20 44 41 25 |
| funding | gov, ngo |
| otherfunding | |
| fundingnameofsponsors | PHRC, Santelys association |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | 04/1999 |
| actualstart | 04/1999 |
| proposedcompletiondate | 12/2003 |
| actualcompletiondate | 12/2003 |
| multi_center_study | no |
| numberofcentres | |
| multi_national_study | no |
| countrycentres | France |
| researchquestion | To compare the rejection rates, graft and patient survivals, and renal fonction after an early (3 months post graft) cyclosporine versus mycophenolate mofetil withdrawal, in de novo renal transplant patients receiving a triple drug regimen (cyclopsorine, mycophenolate mofetil and prednisone) |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | acute rejection, graft survival, patient survival, renal function |
| intervention1 | Cyclosporine (Novartis) |
| intervention2 | Mycophenolate mofetil (Roche) |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | between 18 and 65 |
| totalrecruitment | 106 |
| inclusion | 1) First renal transplantation from a deceased donor under a triple drug regimen (cyclosporine + mycophenolate mofetil + prednisone)
2) No acute rejection episode during the first 3 months post graft (time of randomisation) 3) Patients who gave their informed consent and are able to understand the scope of the study |
| exclusion | 1) Living donneur, re-transplantation
2) Panel ractive antibodies > 30% 3) Serum creatinine > 2.5 mg/dl (222 ?mol/l) 4) Cyclosporine toxicity at the time of randomisation (3 months post graft) 5) Patients with generalized infection at the time of transplantation 6) Women in child-bearing age who do not plan to use efficient contraception 7) Age of donor > 65 |
| primaryoutcomes | Incidence of biopsy-proven acute allograft rejection during the first post-transplant year |
| secondaryoutcomes | 1) Graft function at 1 year.
2) Chronic Allograft Damage Index (CADI) at 1 year. 3) Incidence of adverse events in the two treatment arms at 1 year. 4) Proportion of patients who returned to a triple drug regimen at 1 year. 5) graft and patients survival at 1 year. 6) Pharmaco-economic comparison of the 2 arms. |
| reference | Predictive factors of acute rejection after early cyclosporine withdrawal in renal transplant recipients who receive mycophenolate mofetil: results from a prospective, randomized trial. M Hazzan, M Labalette, MC Copin, F Glowacki, F Provot, FR Pruvot, C Noel. J Am Soc Nephrol. 2005 ; 16 : 2509-2516
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