Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT01790594
Eligibility 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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01790594
Study Brief:
Protocol Section:
NCT01790594