Overview

Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

Status:
Completed

Trial end date:
2006-11-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Hospital, Lille

Collaborator:

Erasme University Hospital

Treatments:

Antilymphocyte Serum
Daclizumab
Immunoglobulin G
Mycophenolate mofetil
Thymoglobulin

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