Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists

NCT00859131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-04-26

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).

Conditions

Interventions

DRUG

Rabbit Antithymocyte globulin

1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4

DRUG

Daclizumab

1.0 mg/kg pre-op and 1.0 mg/kg on Day 7

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Kenneth D Chavin, MD,PhD · Medical University of South Carolina

  • Nicole Pilch, PharmD · Medical University of South Carolina

  • David Taber, PharmD · Medical University of South Carolina

  • Prabhakar Baliga, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT00859131 on ClinicalTrials.gov