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

Primary Purpose

End Stage Renal Disease

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

rituximab

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring transplant, desensitization, kidney transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Decrease in incidence of humoral rejection to less than 50% at 1 year.

Full Information

NCT ID

NCT00167791

First Posted

September 9, 2005

Last Updated

October 13, 2015

Sponsor

University of Wisconsin, Madison

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00167791

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Withdrawn

Why Stopped

lack of enrollment

Study Start Date

July 2005 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

transplant, desensitization, kidney transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

rituximab

Intervention Description

Rituximab 375mg/m2 IV weekly times 4 weeks

Primary Outcome Measure Information:

Title

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

Title

Transplant success or failure following the desensitization protocol.

Time Frame

ongoing assessment for 2 years after transplant

Secondary Outcome Measure Information:

Title

Decrease in incidence of humoral rejection to less than 50% at 1 year.

Time Frame

assess 1 year after transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yolanda T Becker, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Study Chair

Facility Information:

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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