A multicenter open label study to compare efficacy and safety of induction treatment by ATG (thymoglobulin) versus anti-IL-2R (daclizumab) with a triple drug regimen (tacrolimus, mycophenolate mofetil, prednisone) in high risk renal transplant recipients.
- Conditions
- Incidence of acute rejection in renal transplantationRenal and Urogenital - Kidney disease
- Registration Number
- ACTRN12610000071022
- Lead Sponsor
- Centre Hospitalier Regional Universitaire (CHRU) de Lille
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
Patients candidate for renal transplantation who fulfill the following criteria:
1) Third or fourth renal graft or
2) Current anti-Human Leukocyte Antigen (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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of biopsy-proven acute allograft rejection[12 months post transplant]
- Secondary Outcome Measures
Name Time Method