Optimization of NULOJIX� (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation

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

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.

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 Injury

Measures of Cardiovascular and Metabolic Parameters

Incidence and Severity of Rejection and Anti-Donor Reactivity

Safety Outcome Measures

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

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

National Institute of Allergy and Infectious Diseases (NIAID)

Clinical Trials in Organ Transplantation (CTOT)

Starting date: February 2013
Last updated: April 30, 2015