Status:
TERMINATED
Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Clinical Trials in Organ Transplantation
Conditions:
Primary Renal Allograft Candidate
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 c...
Detailed Description
Taking standard anti-rejection medications for a long time can cause serious side effects, including kidney damage. Transplant recipients have to take anti-rejection medications to prevent their immun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01856257
Start Date
July 1 2013
End Date
April 1 2016
Last Update
December 17 2020
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Emory University
Atlanta, Georgia, United States, 30322