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

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00167791
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 0
• Location: 1
• Duration (Months): 32
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jul 1, 2005
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Outcome Measures

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. [assess 4 weeks after Rituximab treatment completed]

2. Transplant success or failure following the desensitization protocol. [ongoing assessment for 2 years after transplant]

Secondary Outcome Measures

1. Decrease in incidence of humoral rejection to less than 50% at 1 year. [assess 1 year after transplant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00167791
• Other Study ID Numbers: H-2004-0265; RIST
• First Posted: Sep 14, 2005
• Last Update Posted: Oct 14, 2015
• Last Verified: Apr 1, 2014

• Keywords provided by University of Wisconsin, Madison: transplant; desensitization; kidney transplant
• Additional relevant MeSH terms: Kidney Failure, Chronic; Rituximab

Study Results

No Results Posted as of Oct 14, 2015