Status:
COMPLETED
Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Erasme University Hospital
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
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 o...
Eligibility Criteria
Inclusion
- Third or fourth renal graft or
- Current anti-HLA antibodies above or equal to 30% at the last evaluation or
- Peak anti-HLA antibodies above or equal to 50% at the last evaluation or
- A second graft if the first was lost within 2 years because of rejection.
- Patients who gave their informed consent and are able to understand the scope of the study
Exclusion
- Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
- Transplantation from a non-heart beating donor
- Transplantation of two kidneys from the same donor
- Patients with generalized infection at the time of transplantation
- Women in child-bearing age who do not plan to use efficient contraception
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT00682292
Start Date
May 1 2001
End Date
November 1 2006
Last Update
May 22 2008
Active Locations (1)
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1
University Hospital of Lille
Lille, France, 59037