Status:
TERMINATED
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Clinical Trials in Organ Transplantation
Conditions:
Kidney Transplantation
Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 n...
Detailed Description
Dialysis or kidney transplant are the two ways to treat kidney failure. Transplant recipients have to take anti-rejection medications to prevent their immune system (the body's natural defense system ...
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 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01436305
Start Date
September 1 2011
End Date
April 1 2015
Last Update
September 27 2017
Active Locations (3)
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1
University of Alabama
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