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Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation

NCT01278745 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2020-08-25

Study results available
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Summary

All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function. People who develop antibodies after transplant have a higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the risk of developing CAV. People who develop CAV usually have to receive another transplant.

Conditions

  • Cardiac Allograft Vasculopathy
  • Heart Transplant Recipients

Interventions

BIOLOGICAL

Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper)

DRUG

Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Clinical Trials in Organ Transplantation

    collaborator NETWORK

  • Genentech, Inc.

    collaborator INDUSTRY

  • Rho Federal Systems Division, Inc.

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Randall Starling, MD · The Cleveland Clinic

  • Mohamed Sayegh, MD · Brigham and Women's Hospital/Harvard

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

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 NCT01278745 on ClinicalTrials.gov