Clinical trial NCT02134288: Belatacept for Renal Transplant Recipients With Delayed Graft Function
Official title: Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Delayed Graft Function
Keywords: Dialysis
Kidney Transplant
immunosuppressive therapy
Delayed Graft Function
Belatacept
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2014-05-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility 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

Primary outcomes:
measure: Time to recover from Delayed Graft Function
timeFrame: 2 weeks
Secondary outcomes:
measure: Percent patients reaching recovery (defined above) by 14 days and 3 months.
timeFrame: Assessed at 3, 6, 12 months
measure: Hospital length of stay (days) from date of transplant to discharge
timeFrame: up to 7 days
measure: Number of dialysis treatments
timeFrame: Assessed at 3, 6, 12 months
measure: Number of biopsies
timeFrame: Assessed at 3, 6, 12 months
measure: Biopsy proven acute rejection events
timeFrame: Assessed at 3, 6, 12 months
measure: Patient and graft survival
timeFrame: Assessed at 3, 6, 12 months
measure: Number of hospital readmissions
timeFrame: Assessed at 3, 6, 12 months
measure: Detection of DSA (Luminex)
timeFrame: Assessed at 3, 6, 12 months
measure: Incidence and type of infection
timeFrame: Assessed at 3, 6, 12 months
measure: Measured or estimated creatinine clearance.
timeFrame: Assessed at 3, 6, 12 months
measure: Banff score of rejection episodes and immune suppression treatment/management of rejection
timeFrame: Assessed at 3, 6, 12 months
measure: Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).
timeFrame: Assessed at 3, 6, 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Universtiy Wexner Medical Center
state: Ohio
Study officials:
affiliation: OSU Wexner Medical Center
name: Jon Von Visger, M.D./Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: