Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

University Hospital, Lille227 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

227

Conditions

Renal Transplantation

Interventions

Thymoglobulin (ATG)DRUG

Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation

DaclizumabDRUG

Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Lille

Lille, France

Outcomes

Primary Outcomes

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

Time frame: acute rejection proved by graft biopsy

Secondary Outcomes

Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.

Time frame: graft dysfunction

Proportion of patients who experienced more than one episode of acute allograft rejection

Time frame: graft dysfunction, biopsies

Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)

Time frame: 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

Time frame: graft dysfunction and biopsies

Banff grade of the first rejection episode

Time frame: graft biopsy

Incidence of adverse events in the two treatment arms at 1 year

Time frame: number of adverse events reported by the investigators

Incidence of delayed graft function

Time frame: number of patient who required hemodialysis during the first week post transplantation

Graft function at 1 year

Time frame: serum creatinine and estimated glomerular filtration rate

Data from ClinicalTrials.gov

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