Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

Stopped early · Phase 2

Conditions studied: Primary Renal Allograft Candidate, Kidney Transplantation

In brief

The primary objective is to evaluate a NULOJIX® (belatacept) based regimens as a means of improving long-term graft function without increasing the risks of immunologic graft injury by avoiding both calcineurin inhibitors (CNIs) and corticosteroids.

Key facts

Study ID

NCT01856257

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

71

Starts

2013-07-01

Expected to finish

2016-04-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female, 18-65 years of age at the time of enrollment;
• Ability to understand and provide written informed consent;
• Candidate for primary renal allograft from either living or deceased donor;
• No known contraindications to study therapy using NULOJIX® (belatacept);
• Female participants of childbearing potential must have a negative pregnancy test upon study entry;
• Participants with reproductive potential must agree to use an appropriate method(s) of birth control as outlined in the CellCept® , Myfortic® or generic package labeling during participation in the study and for 4 months following completion of the study;
• No donor specific antibodies prior to transplant that are considered to be of clinical significance by the site investigator;
• Negative crossmatch or Panel Reactive Antibodies (PRA) of 0% on historic and current sera, as determined by each participating study center;
• A documented negative tuberculosis (TB) test within the 6 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.

You may not qualify if…

• Need for multi-organ transplant;
• Recipient of previous organ transplant;
• Epstein-Barr Virus (EBV) seronegative (or unknown) recipients;
• Active infection including hepatitis B, hepatitis C, or human Immunodeficiency Virus (HIV);
• Individuals who have required treatment with prednisone or other immunosuppressive drugs within 1 year prior to transplant;
• Individuals undergoing transplant using organs from extended criteria donor (ECD) or donation after cardiac death (DCD) donors;
• Histocompatibility antigen (HLA) identical living donors;
• Individuals at significant risk of early recurrence of the primary renal disease including focal segmental glomerulosclerosis (FSGS) and membranoproliferative glomerulonephritis (MPGN) type 2 or any other disease that in the opinion of the investigator is at increased likelihood of recurrence and which may result in rapid decline in renal function;
• Known history of thrombotic events or risk factors, including any of the following:
• Factor V Leiden, elevated homocysteine, positive lupus anticoagulant, elevated anticardiolipin antibody, heparin-induced thrombocytopenia,
• A family history of a heritable thrombotic condition,
• Recurrent deep vein thrombosis (DVT) or pulmonary emboli (PE),
• Unexplained stillborn infant or recurrent spontaneous abortion or other congenital or acquired thrombotic disorder.
• At the discretion of the investigator, a history of thrombosis of a dialysis access graft, fistula, or indwelling catheter/device may not be considered an exclusion criterion.
• 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;
• Blood type A2 and A2B donors into blood type B recipients.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, San Francisco — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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