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Daclizumab Versus Thymoglobulin in Renal Transplant Recipients With High Immunological Risk

NCT00682292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2008-05-22

No results posted yet for this study

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.

Conditions

  • Renal Transplantation

Interventions

DRUG

Thymoglobulin (ATG)

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

DRUG

Daclizumab

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

Sponsors & Collaborators

  • Erasme University Hospital

    collaborator OTHER

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Christian Noël, MD, PhD · University Hospital of Lille, France

  • Daniel Abramowicz, MD, PhD · Erasme Hospital, Bruxelles, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682292 on ClinicalTrials.gov