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