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Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

Information source: University Hospital, Lille
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplantation

Intervention: Thymoglobulin (ATG) (Drug); Daclizumab (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital, Lille

Official(s) and/or principal investigator(s):
Christian Noël, MD, PhD, Principal Investigator, Affiliation: University Hospital of Lille, France
Daniel Abramowicz, MD, PhD, Principal Investigator, Affiliation: Erasme Hospital, Bruxelles, Belgium


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.

Clinical Details

Official title: Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of biopsy-proven acute allograft rejection during the first post-transplant year

Secondary outcome:

Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.

Proportion of patients who experienced more than one episode of acute allograft rejection

Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)

Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm

Banff grade of the first rejection episode

Incidence of adverse events in the two treatment arms at 1 year

Incidence of delayed graft function

Graft function at 1 year

Graft and patient survival at 1 year

Detailed description: The objective of this randomized, multi-center trial is to directly compare the ATG, Thymoglobulin, with the anti-CD25 mAb, daclizumab, in a high-risk, HLA-sensitized renal transplant population, in order to elucidate whether there is any significant difference in the incidence of acute rejection after one year. Eligible patients were randomized (1: 1) to receive either ATG (1. 25 mg/kg/d from day 0 to day 7) or daclizumab (1 mg/kg at days 0, 14, 28, 42 and 56). Maintenance immunosuppression comprised tacrolimus, MMF and prednisone. The study's primary endpoint was the incidence of biopsy-proven acute rejection at one year.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion 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 Criteria: 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

Locations and Contacts

University Hospital of Lille, Lille 59037, France
Additional Information

Starting date: May 2001
Last updated: May 21, 2008

Page last updated: August 23, 2015

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