Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk - Full Text View

Sponsor:	University Hospital, Lille
Collaborator:	Erasme University Hospital
Information provided by:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT00682292

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 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.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Dacliximab

U.S. FDA Resources

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
1, ATG: Active Comparator 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
2, Daclizumab: Active Comparator 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

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:	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 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

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:

Immunologic Factors
Daclizumab
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009