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Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients

NCT00782821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-01-20

Study results available
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Summary

The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Rabbit Antithymocyte Globulin

rATG will be given 1.5mg/kg intravenous (IV) per dose.

DRUG

Velcade

Velcade will be given 1.3mg/m2 via intravenous push (IVP) per dose.

DRUG

Rituxan

Given via IV per group assignment.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • E. Steve Woodle, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00782821 on ClinicalTrials.gov