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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Daclizumab
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014