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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167791
Recruitment Status : Withdrawn (lack of enrollment)
First Posted : September 14, 2005
Last Update Posted : October 14, 2015
Genentech, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
End Stage Renal Disease Drug: rituximab Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Intervention Details:
  • Drug: rituximab
    Rituximab 375mg/m2 IV weekly times 4 weeks

Primary Outcome Measures :
  1. 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 ]
  2. Transplant success or failure following the desensitization protocol. [ Time Frame: ongoing assessment for 2 years after transplant ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00167791     History of Changes
Other Study ID Numbers: H-2004-0265
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: April 2014

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