Renal Transplantation Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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