Renal Transplantation
Conditions
Keywords
Renal transplantation, Immunisation, Acute rejection, Induction therapy, Thymoglobulin, Daclizumab, Rejection in sensitized renal transplant recipients
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 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.
Interventions
Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation
DRUGDaclizumab
Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation
Sponsors
Erasme University Hospital
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of biopsy-proven acute allograft rejection during the first post-transplant year | acute rejection proved by graft biopsy |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who experienced more than one episode of acute allograft rejection | graft dysfunction, biopsies |
| Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3) | number of anti-lymphocyte treatment required for acute rejection episodes |
| Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm | graft dysfunction and biopsies |
| Banff grade of the first rejection episode | graft biopsy |
| Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year. | graft dysfunction |
| Incidence of delayed graft function | number of patient who required hemodialysis during the first week post transplantation |
| Graft function at 1 year | serum creatinine and estimated glomerular filtration rate |
| Graft and patient survival at 1 year | number of graft failures and/or deaths |
| Incidence of adverse events in the two treatment arms at 1 year | number of adverse events reported by the investigators |
Countries
France
Outcome results
None listed