Rituximab Treatment to Block HLA Antibodies in Renal Transplant Recipients

NCT00261547 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-10-23

No results posted yet for this study

Summary

The purpose of this study is to determine if administration of rituximab blocks the development of donor specific antibodies (DSA) in transplant recipients who have developed renal dysfunction and DSA after renal transplant. It is hoped that by blocking DSA production renal function will stabilize or improve.

Conditions

  • Chronic Rejection
  • Kidney Insufficiency

Interventions

DRUG

Rituximab

All subjects will be treated with Rituximab 1000 mg (1 g) intravenously on days 1 and 15.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Nina Tolkoff-Rubin, M.D. · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-11-30
Completion
2007-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00261547 on ClinicalTrials.gov