Optimization of NULOJIX� (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas and Kidney Transplant
Intervention: Belatacept (Biological); methylprednisolone (Drug); Anti-thymocyte Globulin (Biological); Tacrolimus (Drug); Mycophenolate mofetil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s): Kenneth Newell, MD, PhD, Principal Investigator, Affiliation: Emory University
Summary
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 lesson the amount of antirejection medications
you are taking long term.
The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the
amount of other antirejection 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.
Clinical Details
Official title: Optimization of NULOJIX® (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation (CTOT-15)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean glomerular filtration rate (GFR)
Secondary outcome: Measures of Renal Function and InjuryMeasures of Cardiovascular and Metabolic Parameters Incidence and Severity of Rejection and Anti-Donor Reactivity Safety Outcome Measures
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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 PRA of 0% on historic and admission
sera, as determined by each participating study center;
- A documented negative 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;
- 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
Locations and Contacts
University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting Jill Andringa, Phone: 205-934-0035, Email: jillrn@uab.edu Roslyn B Mannon, MD, Principal Investigator
University of California San Francisco Medical Center, San Francisco, California 94143-0780, United States; Recruiting JoAnn Zlatunich, Phone: 415-353-8380, Email: Joann.zlatunich@ucsfmedctr.org Peter G Stock, MD, PhD, Principal Investigator
Emory University, Atlanta, Georgia 30322, United States; Recruiting Sue Mead, Phone: 404-712-1787, Email: Beth.Begley@emoryhealthcare.org Kenneth Newell, MD, PhD, Principal Investigator
Indiana University Hospital, Indianapolis, Indiana 46202, United States; Recruiting Jeanne Chen, Phone: 317-944-3570, Email: jchen@iuhealth.org Jonathan Fridell, MD, Principal Investigator
University of Wisconsin, Madison, Wisconsin 53792, United States; Recruiting Kristi Schneider, Phone: 608-263-7064, Email: schneide@surgery.wisc.edu Jon Odorico Jon Odorico, MD, Principal Investigator
Additional Information
National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation (CTOT)
Starting date: February 2013
Last updated: April 30, 2015
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