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

End Stage Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00167791
• Other study ID #: H-2004-0265
• Secondary ID: RIST
• Status: Withdrawn
• Phase: N/A
• First received: September 9, 2005
• Last updated: October 13, 2015
• Start date: July 2005
• Est. completion date: March 2008

Study information

• Verified date: April 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• rituximab
Rituximab 375mg/m2 IV weekly times 4 weeks

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Transplant success or failure following the desensitization protocol.		ongoing assessment for 2 years after transplant	No
Secondary	Decrease in incidence of humoral rejection to less than 50% at 1 year.		assess 1 year after transplant	Yes