Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation
- Conditions
- DGFKidney Transplant; Complications
- Interventions
- Diagnostic Test: Highly suppressive Treg measurement
- Registration Number
- NCT04414111
- Lead Sponsor
- St. Louis University
- Brief Summary
Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Adult kidney transplant candidates immediately prior to their kidney transplant surgery
- < 18 years old
- Active immunosuppressive drug use
- Hepatitis C
- HIV
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Kidney transplant recipient Highly suppressive Treg measurement Kidney transplant recipient
- Primary Outcome Measures
Name Time Method Delayed graft function 1 week Delayed graft function defined as dialysis requirement within the first week after kidney transplant
Slow graft function 24 hours Slow graft function defined as a serum creatinine drop of less than 20% in the first 24 hours after kidney transplant
- Secondary Outcome Measures
Name Time Method Acute rejection 1 year Kidney allograft biopsy-proven acute rejection according to Banff criteria
Trial Locations
- Locations (2)
Loma Linda University Health Transplantation Institute
🇺🇸San Bernardino, California, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States