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| autoid | 102 |
| crg_id | CRG020600038 |
| titleoftrial | Etude multicentrique, randomisee, ouverte, comparant l\'efficacite et la tolerance d\'un traitement d\'induction par ATG versus un anticorps monoclonal anti-recepteur de l\'IL2 (daclizumab) associe une triple therapie tacrolimus-MMF-steroides chez des greffes renaux haut risque immunologique. |
| acronymnoftrial | TAXI |
| website | http:// |
| identificationno | |
| leadprefix | Prof |
| leadsurname | Noel |
| leadgivennames | Christian |
| leadposition | Head |
| leaddepartment | Nephrology Department |
| leadorganisation | Etablissement hospitalier Calmette - CHRU Lille |
| leadaddress | Bd du Professeur Jules Leclercq 59037 Lille Cedex |
| leademail | cnoel@CHRU-Lille.fr |
| leadphone | +33 320 44 41 42 |
| leadfax | +33 320 44 41 25 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
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| contactfax | |
| funding | industry |
| otherfunding | |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | yes |
| proposedstart | 05/2001 |
| actualstart | 05/2001 |
| proposedcompletiondate | 11/2006 |
| actualcompletiondate | 11/2006 |
| multi_center_study | yes |
| numberofcentres | 16_20 |
| multi_national_study | yes |
| countrycentres | France |
| researchquestion | To compare renal allograft rejection rates during the first year among high-immunological risk recipients between patients who received either ATG or the anti-IL2R mAb daclizumab. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | Renal allograft rejection |
| intervention1 | ATG (genzyme) |
| intervention2 | Zenapax (daclizumab, Roche) |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | Above 18 years of age |
| totalrecruitment | 240 |
| inclusion | Patients candidate for renal transplantation who fulfill the following criteria:
1) Third or fourth renal graft or 2) Current anti-HLA antibodies above or equal to 30% at the last evaluation or 3) Peak anti-HLA antibodies above or equal to 50% at the last evaluation or 4) A second graft if the first was lost within 2 years because of rejection. 5) Patients who gave their informed consent and are able to understand the scope of the study |
| exclusion | 1) Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
2)Transplantation from a non-heart beating donor 3) Transplantation of two kidneys from the same donor 4) Patients with generalized infection at the time of transplantation 5) Women in child-bearing age who do not plan to use efficient contraception |
| primaryoutcomes | Incidence of biopsy-proven acute allograft rejection during the first post-transplant year |
| secondaryoutcomes | 1) Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.
2) Proportion of patients who experienced more than one episode of acute allograft rejection. 3)Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3). 4) Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm. 5) Proportion of patients who experienced at least one steroid-resistant acute rejection episode. 6) Banff grade of the first rejection episode. 7) Incidence of adverse events in the two treatment arms at 1 year. 8) Incidence of delayed graft function. 9) Graft function at 1 year. 10) Graft and patient survival at 1 year. |
| reference | Noel C, Abramowicz D, Durand D, Mourad G, Lang P, Kessler M, et al. Daclizumab versus antithymocyte globulin in high-immunological-risk renal transplant recipients.[see comment]. Journal of the American Society of Nephrology 2009 Jun;20(6):1385-92. |