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

University of Wisconsin, Madison

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

End Stage Renal Disease

Interventions

rituximabDRUG

Rituximab 375mg/m2 IV weekly times 4 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Time frame: assess 1 year after transplant

Data from ClinicalTrials.gov

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