Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant - Full Text View

Purpose

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	Intervention
End Stage Renal Disease	Drug: rituximab

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Transplant success or failure following the desensitization protocol. [ Time Frame: ongoing assessment for 2 years after transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decrease in incidence of humoral rejection to less than 50% at 1 year. [ Time Frame: assess 1 year after transplant ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	July 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Rituximab 375mg/m2 IV weekly times 4 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167791

Locations


United States, Wisconsin
	University of Wisconsin
	Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Genentech

Investigators


Study Chair:	Yolanda T Becker, MD	University of Wisconsin, Madison

More Information

Responsible Party:	University of WIsconsin ( Yolanda Becker, MD )
Study ID Numbers:	2004-0265, RIST
First Received:	September 9, 2005
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00167791
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

transplant

desensitization

kidney transplant

Study placed in the following topic categories:

Renal Insufficiency

Urologic Diseases

Rituximab

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

Additional relevant MeSH terms:

Immunologic Factors

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	University of Wisconsin, Madison Genentech
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00167791