NCT00167791

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

October 14, 2015

Status Verified

April 1, 2014

Enrollment Period

2.7 years

First QC Date

September 9, 2005

Last Update Submit

October 13, 2015

Conditions

End Stage Renal Disease

Keywords

transplantdesensitizationkidney transplant

Outcome Measures

Primary Outcomes (2)

  • 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

  • Transplant success or failure following the desensitization protocol.

    ongoing assessment for 2 years after transplant

Secondary Outcomes (1)

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

    assess 1 year after transplant

Interventions

rituximabDRUG

Rituximab 375mg/m2 IV weekly times 4 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active status on a kidney transplant waiting list with positive cross match against a living donor

You may not qualify if:

  • Receipt of a live vaccine within 4 weeks prior to randomization
  • Previous Treatment with Rituximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Yolanda T Becker, MD

    University of Wisconsin, Madison

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

October 14, 2015

Record last verified: 2014-04

Locations

US(1)