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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Clinical Trials in Organ Transplantation
• Treatments: Abatacept; Antibodies, Monoclonal; Antilymphocyte Serum; Basiliximab; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.