Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk (TAXI)

This study has been completed.
Sponsor:
Collaborator:
Erasme University Hospital
Information provided by:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00682292
First received: May 20, 2008
Last updated: May 21, 2008
Last verified: February 2004
  Purpose

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.


Condition Intervention Phase
Renal Transplantation
Drug: Thymoglobulin (ATG)
Drug: Daclizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Study to Compare Induction Therapy With Polyclonal Antithymocytes Globulins (ATG) Versus Monoclonal Anti-IL2R Antibody (Daclizumab) in a Triple Drug Regimen in Renal Transplant Recipients With High Immunological Risk.

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • Incidence of biopsy-proven acute allograft rejection during the first post-transplant year [ Time Frame: acute rejection proved by graft biopsy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year. [ Time Frame: graft dysfunction ] [ Designated as safety issue: No ]
  • Proportion of patients who experienced more than one episode of acute allograft rejection [ Time Frame: graft dysfunction, biopsies ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Banff grade of the first rejection episode [ Time Frame: graft biopsy ] [ Designated as safety issue: No ]
  • Incidence of adverse events in the two treatment arms at 1 year [ Time Frame: number of adverse events reported by the investigators ] [ Designated as safety issue: Yes ]
  • Incidence of delayed graft function [ Time Frame: number of patient who required hemodialysis during the first week post transplantation ] [ Designated as safety issue: Yes ]
  • Graft function at 1 year [ Time Frame: serum creatinine and estimated glomerular filtration rate ] [ Designated as safety issue: No ]
  • Graft and patient survival at 1 year [ Time Frame: number of graft failures and/or deaths ] [ Designated as safety issue: Yes ]

Enrollment: 227
Study Start Date: May 2001
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1, ATG
Thymoglobulin induction during 8 days (1.25 mg/kg per day) associated with tacrolimus, mycophenolate mofetil and steroids
Drug: Thymoglobulin (ATG)
Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation
Other Name: Thymoglobulin, Genzyme
Active Comparator: 2, Daclizumab
Dacluzamb induction (five infusions, 1 mg/kg per infusion) associated with tacrolimus, mycophenolate mofetil and steroids
Drug: Daclizumab
Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation
Other Name: Zenapax, Roche

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682292

Locations
France
University Hospital of Lille
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Erasme University Hospital
Investigators
Principal Investigator: Christian Noël, MD, PhD University Hospital of Lille, France
Principal Investigator: Daniel Abramowicz, MD, PhD Erasme Hospital, Bruxelles, Belgium
  More Information

No publications provided

Responsible Party: Noël Christian, MD, PhD, Professor of Nephrology, University Hospital of Lille
ClinicalTrials.gov Identifier: NCT00682292     History of Changes
Other Study ID Numbers: UHLillle, CRG020600038
Study First Received: May 20, 2008
Last Updated: May 21, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Lille:
Renal transplantation
Immunisation
Acute rejection
Induction therapy
Thymoglobulin
Daclizumab
Rejection in sensitized renal transplant recipients

Additional relevant MeSH terms:
Antilymphocyte Serum
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014