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

This study has been withdrawn prior to enrollment.
(lack of enrollment)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00167791
First received: September 9, 2005
Last updated: April 4, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
  • Transplant success or failure following the desensitization protocol. [ Time Frame: ongoing assessment for 2 years after transplant ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167791

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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00167791     History of Changes
Other Study ID Numbers: 2004-0265, RIST
Study First Received: September 9, 2005
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 30, 2014