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Sponsors and Collaborators: |
University Hospital, Lille Erasme University Hospital |
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Information provided by: | University Hospital, Lille |
ClinicalTrials.gov Identifier: | NCT00682292 |
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 |
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Renal Transplantation |
Drug: Thymoglobulin (ATG) Drug: Daclizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study |
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. |
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 |
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1, ATG: Active Comparator
Thymoglobulin induction during 8 days (1.25 mg/kg per day) associated with tacrolimus, mycophenolate mofetil and steroids
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Drug: Thymoglobulin (ATG)
Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation
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2, Daclizumab: Active Comparator
Dacluzamb induction (five infusions, 1 mg/kg per infusion) associated with tacrolimus, mycophenolate mofetil and steroids
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Drug: Daclizumab
Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
University Hospital of Lille | |
Lille, France, 59037 |
Principal Investigator: | Christian Noël, MD, PhD | University Hospital of Lille, France |
Principal Investigator: | Daniel Abramowicz, MD, PhD | Erasme Hospital, Bruxelles, Belgium |
Responsible Party: | University Hospital of Lille ( Noël Christian, MD, PhD, Professor of Nephrology ) |
Study ID Numbers: | UHLillle, CRG020600038 |
Study First Received: | May 20, 2008 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00682292 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Renal transplantation Immunisation Acute rejection Induction therapy |
Thymoglobulin Daclizumab Rejection in sensitized renal transplant recipients |
Antilymphocyte Serum Antibodies Daclizumab Immunoglobulins |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |