Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant

October 13, 2015 updated by: University of Wisconsin, Madison

Multicenter Trial Using Multi-dose Rituximab as Induction and Desensitization Therapy for Patients on the Waiting List for Kidney Transplant With a Positive Donor Specific Crossmatch to a Living Donor

This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active status on a kidney transplant waiting list with positive cross match against a living donor

Exclusion Criteria:

  • Receipt of a live vaccine within 4 weeks prior to randomization
  • Previous Treatment with Rituximab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation.
Time Frame: assess 4 weeks after Rituximab treatment completed
assess 4 weeks after Rituximab treatment completed
Transplant success or failure following the desensitization protocol.
Time Frame: ongoing assessment for 2 years after transplant
ongoing assessment for 2 years after transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease in incidence of humoral rejection to less than 50% at 1 year.
Time Frame: assess 1 year after transplant
assess 1 year after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Genentech, Inc.

Investigators

  • Study Chair: Yolanda T Becker, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2004-0265
  • RIST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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