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

This study has been withdrawn prior to enrollment.
(lack of enrollment)
Genentech, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 9, 2005
Last updated: October 13, 2015
Last verified: April 2014
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.

Condition Intervention
End Stage Renal Disease
Drug: rituximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ]
  • Transplant success or failure following the desensitization protocol. [ Time Frame: ongoing assessment for 2 years after transplant ]

Secondary Outcome Measures:
  • Decrease in incidence of humoral rejection to less than 50% at 1 year. [ Time Frame: assess 1 year after transplant ]

Enrollment: 0
Study Start Date: July 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rituximab
    Rituximab 375mg/m2 IV weekly times 4 weeks

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00167791

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Genentech, Inc.
Study Chair: Yolanda T Becker, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00167791     History of Changes
Other Study ID Numbers: H-2004-0265
Study First Received: September 9, 2005
Last Updated: October 13, 2015

Keywords provided by University of Wisconsin, Madison:
kidney transplant

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 25, 2017