NCT00682292

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
Last Updated

May 22, 2008

Status Verified

February 1, 2004

Enrollment Period

5.5 years

First QC Date

May 20, 2008

Last Update Submit

May 21, 2008

Conditions

Renal Transplantation

Keywords

Renal transplantationImmunisationAcute rejectionInduction therapyThymoglobulinDaclizumabRejection in sensitized renal transplant recipients

Outcome Measures

Primary Outcomes (1)

  • Incidence of biopsy-proven acute allograft rejection during the first post-transplant year

    acute rejection proved by graft biopsy

Secondary Outcomes (9)

  • Proportion of patients who experienced an acute rejection episode, whether confirmed by biopsy or not at 1 year.

    graft dysfunction

  • Proportion of patients who experienced more than one episode of acute allograft rejection

    graft dysfunction, biopsies

  • Proportion of patients who experienced an acute rejection episode that required therapy by anti-lymphocyte antibodies (ATG or OKT3)

    number of anti-lymphocyte treatment required for acute rejection episodes

  • Number of acute rejection episodes per therapeutic arms and mean number of acute rejection episode per patient in each arm

    graft dysfunction and biopsies

  • Banff grade of the first rejection episode

    graft biopsy

  • +4 more secondary outcomes

Study Arms (2)

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)

2, Daclizumab

ACTIVE COMPARATOR

Dacluzamb induction (five infusions, 1 mg/kg per infusion) associated with tacrolimus, mycophenolate mofetil and steroids

Drug: Daclizumab

Interventions

Thymoglobulin (ATG)DRUG

Thymoglobulin: 1.25 mg/kg per day from day 0 to day 7 post transplantation

Also known as: Thymoglobulin, Genzyme
1, ATG
DaclizumabDRUG

Daclizumab: 1mg/kg at day 0, 14, 28, 42 and 56 post transplantation

Also known as: Zenapax, Roche
2, Daclizumab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Lille

Lille, 59037, France

Location

MeSH Terms

Interventions

thymoglobulinDaclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Christian Noël, MD, PhD

    University Hospital of Lille, France

    PRINCIPAL INVESTIGATOR

  • Daniel Abramowicz, MD, PhD

    Erasme Hospital, Bruxelles, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

May 1, 2001

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

May 22, 2008

Record last verified: 2004-02

Locations

FR(1)