NCT04414111

Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation

Highly Suppressive Treg as a Biomarker for Immunologically Relevant Delayed (DGF) and Slow (SGF) Graft Function After Kidney Transplantation

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• DGF
• Kidney Transplant; Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Highly suppressive Treg measurement	Circulating highly suppressive Treg measurement

Timeline

• Start date: 2020-12-07
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2020-06-04
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States