Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess whether a new drug, Nulojix® (belatacept), would minimize serious long term side effects associated with anti-rejection medications while still protecting the new kidney from damage. The researchers also wanted to learn more about the safety of this treatment and long term health of the transplanted kidney.

• 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; Alemtuzumab; Antibodies, Monoclonal; Basiliximab; Calcineurin Inhibitors; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus

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 a 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;

• 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 completion of the study;

• Flow-based PRA within last 12 months (in absence of a sensitizing event) of < 30% as determined by each participating study center. If the subject experienced a sensitizing event after the PRA test date, then the PRA must be repeated and confirmed <30%;

• Negative crossmatch 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 transplant;

• Recipient of previous organ transplant;

• EBV sero-negative (or unknown) recipients;

• Active infection including hepatitis B, hepatitis C, or 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;

• HLA identical living donors;

• Individuals at significant risk of early recurrence of the primary renal disease including FSGS and 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;

• 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.