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

NCT ID: NCT00167791

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-03-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rituximab

Rituximab 375mg/m2 IV weekly times 4 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yolanda T Becker, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

RIST

Identifier Type: -

Identifier Source: secondary_id

H-2004-0265

Identifier Type: -

Identifier Source: org_study_id