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



Status:Terminated
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:September 2011
End Date:August 2015

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Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation (CTOT-11)

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.
The purpose of this research study is to see if a study drug called Rituximab prevents CAV.
Rituximab destroys certain types of white blood cells called B cells. B cells are important
cells in the immune system that help the body fight infection by producing substances called
antibodies. B cells and the antibodies they produce are also involved in some kinds of
rejection after organ transplantation. Rituximab decreases the number of B cells in the
blood and other tissues. The goal of this study is to determine if decreasing B cells with
Rituximab can prevent injury to the transplanted heart.


Inclusion Criteria for Initial Enrollment:

- Subject must be able to understand and provide informed consent;

- Male or Female, 18 to 75 years of age;

- Candidate for a primary heart transplant;

- All previous PRA testing <30%LABScreen® PRA Class I and II with an MFI of <2000 or
less than 10% by LABScreen® Single Antigen with an MFI <2000 at the time of
transplant (Local HLA Center Testing);

- Calculated GFR >40 mL/minute using the Chronic Kidney Disease Epidemiology
Collaboration equation (CKD-EPI) ;

- Female and male subjects with reproductive potential, must agree to use FDA approved
methods of birth control for the duration of the study

Inclusion Criteria for Randomization / Post-transplant:

- Negative PRA within 12 weeks prior to transplant (Local HLA Center Testing) using one
of the following:

1. One Lambda's LABScreen® Mixed Class I & II, or

2. Less than 10% by One Lambda's LABScreen® PRA Class I and II with an MFI of
<2000, or

3. cPRA less than 10% by LABScreen® Single Antigen testing (Anti-HLA-A, B, DR, DQ).
The antigens reported will include those with an MFI >2000.

The Luminex Gen-Probe beads are equivalent to the One Lambda and may be used as
an alternative ;

- Calculated GFR >40mL/minute using the Chronic Kidney Disease Epidemiology
Collaboration equation (CKD-EPI) at time of randomization ;

- Serum IgG Immunoglobulin level greater than 500mg/dL within 90 days prior to
randomization;

- Negative test for HIV, HBsAg, HBcAb, and HCV Ab within 12 months prior to transplant.
If documentation is not present to support that the testing was performed in the past
12 months, then a blood sample will be collected prior to transplant and sent for
local testing. Results may be available after randomization. If positive result, the
oversight committee will review the case and provide further recommendations.

- Female subjects of childbearing potential must have a negative pregnancy test.

Exclusion Criteria for Enrollment:

- Prior history of organ transplantation- Prior history of organ transplantation;

- Previous treatment with Rituximab (MabThera® / Rituxan ®);

- Intention to use any induction agents;

- History of severe allergic anaphylactic reactions to humanized or murine monoclonal
antibodies;

- History of severe reaction to previous therapy with IVIG;

- Lack of IV venous access;

- Active systemic infection at time of enrollment;

- Any history of Serologic positivity to HIV, HBsAg, HBcAb, and HCV Ab;

- History of malignancy except adequately treated in-situ cervical carcinoma, or
adequately treated basal or squamous cell carcinoma of the skin;

- Any condition that, in the opinion of the investigator, would interfere with the
subject's ability to comply with study requirements;

- Use of other investigational drugs within 4 weeks of enrollment;

- Currently breast-feeding or plans to become pregnant during the timeframe of the
study follow-up period.

Exclusion Criteria for Randomization/Post-transplant:

- Recipient of multiple solid organ or tissue transplants;

- Previous treatment with Rituximab (MabThera® / Rituxan ®);

- Use of any induction agents;

- History of severe allergic anaphylactic reactions to humanized or murine monoclonal
antibodies;

- History of severe reaction to previous therapy with IVIG;

- Lack of IV venous access;

- Active systemic infection at time of randomization;

- Any history of serologic positivity to HIV, HBsAg, HBcAb and HCV Ab;

- Any condition that, in the opinion of the investigator, would interfere with the
subject's ability to comply with study requirements;

- Use of other investigational drugs within 4 weeks prior to randomization;

- Receipt of a live vaccine within 30 days prior to randomization;

- Currently breast-feeding or plans to become pregnant during the timeframe of the
study follow-up period.
We found this trial at
26
sites
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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Philadelphia, PA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
1511
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Minneapolis, MN
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Beverly Hills, California 90211
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Beverly Hills, CA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Dallas, TX
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90095
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Los Angeles, CA
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Murray, UT
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New Haven, Connecticut 16510
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New York, New York 10029
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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Palo Alto, California 94304
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Palo Alto, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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San Francisco, California 94143
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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