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Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies

NCT00307125 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 757

Last updated 2015-03-23

Study results available
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Summary

The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.

Conditions

  • Kidney Transplant
  • Kidney Transplant Recipient
  • Graft Function/Survival
  • de Novo HLA Antibodies Development

Interventions

DRUG

Rituximab plus immunosuppression

Genetically engineered monoclonal antibody directed against the CD20 antigen on B cells and is known to deplete B cells when administered intravenously. Generally used in the treatment of non-Hodgkin's lymphoma Standard immunosuppression is site-specific.

DRUG

Placebo plus immunosuppression

Placebo dosing: Adult Dosing (Subjects \>18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject \<\\=18 years): 375 mg/m\^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22). Standard immunosuppression is site-specific.

Sponsors & Collaborators

  • Clinical Trials in Organ Transplantation

    collaborator NETWORK

  • Cooperative Clinical Trials in Pediatric Transplantation (CCTPT)

    collaborator UNKNOWN

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Mohamed H. Sayegh, MD · Brigham and Women's Hospital

  • William Harmon, MD · Boston Children's Hospital

  • Anil Chandraker, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT00307125 on ClinicalTrials.gov