Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk (TAXI)
This study has been completed.
Sponsor:
University Hospital, Lille
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
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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:
- Third or fourth renal graft or
- Current anti-HLA antibodies above or equal to 30% at the last evaluation or
- Peak anti-HLA antibodies above or equal to 50% at the last evaluation or
- A second graft if the first was lost within 2 years because of rejection.
- Patients who gave their informed consent and are able to understand the scope of the study
Exclusion Criteria:
- Transplantation from living donors or recipients of multiple grafts or patients who already have received another (non-renal) allograft.
- Transplantation from a non-heart beating donor
- Transplantation of two kidneys from the same donor
- Patients with generalized infection at the time of transplantation
- 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 May 16, 2013