Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation



Status:Terminated
Healthy:No
Age Range:18 - 55
Updated:12/9/2017
Start Date:February 2013
End Date:August 2016

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Optimization of NULOJIX® (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation (CTOT-15)

The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the
amount of other anti-rejection medications necessary and thereby reduce the long-term side
effects caused by the other medications. The researchers also want to learn more about the
safety of this treatment and long term health of transplanted pancreases and kidneys.

Transplant recipients have to take anti-rejection medications to prevent their immune systems
(the body's natural defense system against illness) from rejecting their new organs. Most
patients who receive a transplanted organ must take these anti-rejection medications for the
rest of their lives, or for as long as the transplanted organ continues to work. Taking
standard anti-rejection medications for a long time can cause serious side effects, including
pancreas and kidney damage. There would be a benefit to finding new anti-rejection
medications that work just as well, but could lessen the amount of anti-rejection medications
that are taken long term.

Inclusion Criteria:

- Ability to understand and provide written informed consent;

- Candidate for a primary simultaneous kidney and pancreas allograft with random
c-peptide <0.3 ng/mL;

- No known contraindications to study therapy using NULOJIX® (belatacept);

- Female subjects of childbearing potential must have a negative pregnancy test upon
study entry;

- Female and male participants with reproductive potential must agree to use FDA
approved methods of birth control during participation in the study and for 4 months
following study completion;

- No donor specific antibodies prior to transplant that are considered to be of clinical
significance by the site investigator;

- Negative crossmatch, actual or virtual, or a Panel Reactive Antibodies (PRA) of 0% on
historic and admission sera, as determined by each participating study center;

- A documented negative Tuberculosis (TB) test within the 12 months prior to transplant.
If documentation is not present at the time of transplantation, and the subject does
not have any risk factors for TB, a TB-specific interferon gamma release assay (IGRA)
may be performed.

Exclusion Criteria:

- Need for multi-organ transplantation other than a kidney and pancreas;

- Recipient of previous organ transplant;

- Epstein-Barr Virus (EBV) sero-negative recipients or recipients whose EBV serostatus
is unknown prior to the time of transplantation;

- Individuals infected by the hepatitis B or C viruses or HIV;

- Individuals who have required treatment with systemic prednisone or other
immunosuppressive drugs within 1 year prior to transplant;

- Individuals previously treated with NULOJIX® (belatacept);

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

- Use of investigational drugs within 4 weeks of enrollment;

- Known hypersensitivity to mycophenolate mofetil (MMF)or any of the drug's components;

- Administration of live attenuated vaccine(s) within 8 weeks of enrollment.
We found this trial at
5
sites
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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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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550 University Boulevard
Indianapolis, Indiana 46202
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Indianapolis, IN
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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San Francisco, CA
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