We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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This study has been withdrawn prior to enrollment.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
September 9, 2005
September 14, 2005
October 14, 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 ]
  • Transplant success or failure following the desensitization protocol. [ Time Frame: ongoing assessment for 2 years after transplant ]
  • 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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
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