Delayed Graft Function
Conditions
Keywords
Dialysis, Kidney Transplant, immunosuppressive therapy, Delayed Graft Function, Belatacept
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).
Interventions
DRUGBelatacept
DRUGEverolimus
Sponsors
Bristol-Myers Squibb
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recover from Delayed Graft Function | 2 weeks | For renal transplant recipients with DGF, time (days) to recover from DGF as defined as: date of enrollment (day 1) until calculated MDRD IV eGFR at least 21 ml/min: at least 2 days after last dialysis if meeting dialysis criteria for enrollment (end date) and no requirement for dialysis at least 2 weeks, with a stable or improving MDRD calculated eGFR (assessed weekly for at least three weeks). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay (days) from date of transplant to discharge | up to 7 days | by monitoring patient while inpatient |
| Number of dialysis treatments | Assessed at 3, 6, 12 months | by monitoring patients health at each visit, and notification of hospitalizations/AE's |
| Number of biopsies | Assessed at 3, 6, 12 months | medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period |
| Biopsy proven acute rejection events | Assessed at 3, 6, 12 months | by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's |
| Patient and graft survival | Assessed at 3, 6, 12 months | by monitoring patients health at each visit, and notification of hospitalizations/AE's |
| Percent patients reaching recovery (defined above) by 14 days and 3 months. | Assessed at 3, 6, 12 months | Percent patients reaching recovery (defined above) by 14 days and 3 months. |
| Detection of DSA (Luminex) | Assessed at 3, 6, 12 months | by blood draw |
| Incidence and type of infection | Assessed at 3, 6, 12 months | by monitoring patients health at each visit, and notification of hospitalizations/AE's |
| Measured or estimated creatinine clearance. | Assessed at 3, 6, 12 months | by blood draw |
| Banff score of rejection episodes and immune suppression treatment/management of rejection | Assessed at 3, 6, 12 months | by monitoring patients health at each visit, and notification of hospitalizations/AE's |
| Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored). | Assessed at 3, 6, 12 months | by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's |
| Number of hospital readmissions | Assessed at 3, 6, 12 months | by monitoring patients health at each visit, and notification of hospitalizations/AE's |
Countries
United States
Outcome results
None listed