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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This study has been withdrawn prior to enrollment.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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167791
First Posted: September 14, 2005
Last Update Posted: October 14, 2015
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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: 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

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
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00167791


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00167791     History of Changes
Other Study ID Numbers: H-2004-0265
RIST
First Submitted: September 9, 2005
First Posted: September 14, 2005
Last Update Posted: October 14, 2015
Last Verified: April 2014

Keywords provided by University of Wisconsin, Madison:
transplant
desensitization
kidney transplant

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents