Overview

Belatacept for Renal Transplant Recipients With Delayed Graft Function

Status:
Terminated
Trial end date:
2019-01-18
Target enrollment:
0
Participant gender:
All
Summary
Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ohio State University
Von Visger, Jon, MD
Collaborator:
Bristol-Myers Squibb
Treatments:
Abatacept
Everolimus
Sirolimus
Criteria
Inclusion Criteria:

1. Signed Written Informed Consent

2. Deceased donor renal transplant recipient

3. Men and women, aged 18-60 years of age

Exclusion Criteria:

1. Seronegative or unknown EBV serostatus

2. Patients unwilling or incapable of providing informed consent.

3. Patients with active tuberculosis or positive TB test without evidence of infection
treatment.

4. Patients with demonstrated acute rejection on first biopsy evaluation for delayed
graft function; Second transplant or multiple organ transplant; patients more than 12
days post renal transplant prior to enrollment

5. Evidence of Sepsis or other clinical indicators deemed clinically contraindicated for
study enrollment by the primary physician

6. Inadequate vein access to receive monthly IV infusions

7. Prior proven allergy or severe adverse drug reaction to mycophenolate, steroid or
Belatacept preventing therapy.

8. Pregnant women or women of child bearing age not willing to commit to dual
contraception prophylaxis

9. Use of alemtuzumab (Campath 1-H©), basilixumab (Simulect©) and daclizumab (Zenapax©)
are not permitted in this protocol; Use of other immunosuppressive agents must be
limited to those specified in this protocol.

10. Prisoners or subjects who are involuntarily incarcerated.

11. Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness.

12. Pre-sensitized patients with alloscreen antibody levels of 80% or more class I or
class II