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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This study has been withdrawn prior to enrollment.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:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00167791
First received: September 9, 2005
Last updated: October 13, 2015
Last verified: April 2014

September 9, 2005
October 13, 2015
July 2005
March 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation.
  • Transplant success or failure following the desensitization protocol.
Complete list of historical versions of study NCT00167791 on ClinicalTrials.gov Archive Site
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 ]
Decrease in incidence of humoral rejection to less than 50% at 1 year.
Not Provided
Not Provided
 
Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
End Stage Renal Disease
Drug: rituximab
Rituximab 375mg/m2 IV weekly times 4 weeks
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167791
H-2004-0265, RIST
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Genentech, Inc.
Study Chair: Yolanda T Becker, MD University of Wisconsin, Madison
University of Wisconsin, Madison
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP