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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT01278745
Phase
PHASE2
Status
Terminated

Conditions

  • Cardiac Allograft Vasculopathy
  • Heart Transplant Recipients

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2011
Status verified
Aug 2020
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
362 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Rituximab
    Rituximab induction/conventional immunosuppression
  • Placebo Comparator: Rituximab Placebo
    Rituximab Placebo / conventional immunosuppression

Primary Outcome Measure

Change in Percent Atheroma Volume (PAV) [ Time Frame: Baseline, 1 year ]

Locations (24)

FacilityCityStateZIPSite coordinators
Cedars Sinai Heart InstituteBeverly HillsCalifornia90211-
Ronald Regan UCLA Medical CenterLos AngelesCalifornia90095-
Stanford University/Palo Alto VAPalo AltoCalifornia94304-
University of California San FranciscoSan FranciscoCalifornia94143-0124-
Stanford UniversityStanfordCalifornia94305-
Northwestern UniversityChicagoIllinois60611-
University of MarylandBaltimoreMaryland21201-
Brigham and Women's HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
Minneapolis Heart InstituteMinneapolisMinnesota55407-
University of MinnesotaMinneapolisMinnesota55455-
Columbia University Medical CenterNew YorkNew York10032'-
Mount Sinai School of MedicineNew YorkNew York10029-
Cleveland Clinic FoundationClevelandOhio44195-
Drexel University College of MedicinePhiladelphiaPennsylvania19102-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Medical City Dallas Hospital/CRSTIDallasTexas75230-
The Methodist HospitalHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84157-
University of UtahSalt Lake CityUtah84132-2401-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Beverly Hills, CA

By research site
Cedars Sinai Heart Institute· Beverly Hills, CARonald Regan UCLA Medical Center· Los Angeles, CAStanford University/Palo Alto VA· Palo Alto, CAUniversity of California San Francisco· San Francisco, CAStanford University· Stanford, CANorthwestern University· Chicago, IL

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