CompletedPhase 3

Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

France227 participantsStarted 2001-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

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

Timeframe: acute rejection proved by graft biopsy

Trial details

NCT IDNCT00682292

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-11

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