Belatacept for Renal Transplant Recipients With Delayed Graft Function

The Ohio State University

Status and phase: Terminated; Early Phase 1

Conditions: Delayed Graft Function

Treatments: Drug: Everolimus; Drug: Belatacept

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02134288

2013H0312 (Other Identifier)

IM103-336

Details and patient eligibility

About

Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.

Full description

Patients who undergo kidney transplantation require long term immunosuppressive therapy (therapy that reduces your body's ability to respond to anything foreign) to prevent damage to the graft, and some experience delayed graft function (DGF, a condition in which the transplanted kidney does not function properly) after transplantation. This study is being conducted to determine if kidney transplant recipients with delayed graft function (DGF) who are switched to the immunosuppressive regimen of belatacept with mycophenolate and steroid will recover from delayed graft function (DGF) in less time (which could potentially lower the risk of rejection associated with delayed graft function) than kidney transplant recipients with delayed graft function (DGF) who remain on the current standard immunosuppressive regimen (standard of care).

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Belatacept

Active Comparator group

Description:

Belatacept 10mg/kg administered intravenously on days 1, 4, 15, and 28, weeks 8 and 12. Then continue at 5mg/kg every 4 weeks throughout the completion of the study.

Treatment:

Drug: Belatacept

Everolimus

Active Comparator group

Description:

Everolimus 1.5 mg/kg twice a day by mouth, the dose will be adjusted after Day 3.

Treatment:

Drug: Everolimus