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Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

NCT ID: NCT00682292

Last Updated: 2008-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Transplantation

Keywords

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Renal transplantation Immunisation Acute rejection Induction therapy Thymoglobulin Daclizumab Rejection in sensitized renal transplant recipients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1, ATG

Thymoglobulin induction during 8 days (1.25 mg/kg per day) associated with tacrolimus, mycophenolate mofetil and steroids

Group Type ACTIVE_COMPARATOR

Thymoglobulin (ATG)

Intervention Type DRUG

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

2, Daclizumab

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

Group Type ACTIVE_COMPARATOR

Daclizumab

Intervention Type DRUG

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

Interventions

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Thymoglobulin (ATG)

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

Intervention Type DRUG

Daclizumab

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

Intervention Type DRUG

Other Intervention Names

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Thymoglobulin, Genzyme Zenapax, Roche

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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University Hospital of Lille

Principal Investigators

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Christian Noël, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lille, France

Daniel Abramowicz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasme Hospital, Bruxelles, Belgium

Locations

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University Hospital of Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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CRG020600038

Identifier Type: -

Identifier Source: secondary_id

UHLillle

Identifier Type: -

Identifier Source: org_study_id