Clinical Trial: Belatacept for Renal Transplant Recipients With Delayed Graft Function

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective, Randomized Trial of Belatacept Switch in Renal Transplant Recipients With Delayed Graft Function

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 Summary: 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).
Sponsor: Von Visger, Jon, MD

Current Primary Outcome: Time to recover from Delayed Graft Function [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent patients reaching recovery (defined above) by 14 days and 3 months. [ Time Frame: Assessed at 3, 6, 12 months ]
    Percent patients reaching recovery (defined above) by 14 days and 3 months.
  • Hospital length of stay (days) from date of transplant to discharge [ Time Frame: up to 7 days ]
    by monitoring patient while inpatient
  • Number of dialysis treatments [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's
  • Number of biopsies [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's
  • Number of hospital readmissions [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's
  • Detection of DSA (Luminex) [ Time Frame: Assessed at 3, 6, 12 months ]
    by blood draw
  • Incidence and type of infection [ Time Frame: Assessed at 3, 6, 12 months ]
    by monitoring patients health at each visit, and notification of hospitalizations/AE's
  • Measured or estimated creatinine clearance. [ Time Frame: Assessed at 3, 6, 12 months ]
    by blood draw
  • Banff score of rejection episodes and immune suppression treatment/management of rejection [ Time Frame: 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). [ Time Frame: Assessed at 3, 6, 12 months ]
    by blood draw, and by monitoring patients health at each visit, and notification of hospitalizations/AE's


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: April 21, 2014
Date Started: April 2014
Date Completion: December 2017
Last Updated: January 23, 2017
Last Verified: January 2017