Currently looking for individuals that have received a kidney transplant, are experiencing delayed graft function (DGF), and meet the criteria for study participation.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The Ohio State Universtiy Wexner Medical Center
Columbus, Ohio, United States
Time to recover from Delayed Graft Function
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).
Time frame: 2 weeks
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Percent patients reaching recovery (defined above) by 14 days and 3 months.
Time frame: Assessed at 3, 6, 12 months
Hospital length of stay (days) from date of transplant to discharge
by monitoring patient while inpatient
Time frame: up to 7 days
Number of dialysis treatments
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time frame: Assessed at 3, 6, 12 months
Number of biopsies
medical record review of clinically indicated renal allograft biopsies performed within the followup 12 month period
Time frame: Assessed at 3, 6, 12 months
Biopsy proven acute rejection events
by blood draws, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time frame: Assessed at 3, 6, 12 months
Patient and graft survival
by monitoring patients health at each visit, and notification of hospitalizations/AE's
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Assessed at 3, 6, 12 months
Number of hospital readmissions
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time frame: Assessed at 3, 6, 12 months
Detection of DSA (Luminex)
by blood draw
Time frame: Assessed at 3, 6, 12 months
Incidence and type of infection
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time frame: Assessed at 3, 6, 12 months
Measured or estimated creatinine clearance.
by blood draw
Time frame: Assessed at 3, 6, 12 months
Banff score of rejection episodes and immune suppression treatment/management of rejection
by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time frame: Assessed at 3, 6, 12 months
Immune suppression drug levels (everolimus or sirolimus, cyclosporine, or mycophenolate as clinically monitored).
by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's
Time frame: Assessed at 3, 6, 12 months