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ACTIVE NOT RECRUITING
NCT04414111

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

Sponsor: St. Louis University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2020-12-07

Completion Date

2027-07-31

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Highly suppressive Treg measurement

Circulating highly suppressive Treg measurement

Locations (2)

Loma Linda University Health Transplantation Institute

San Bernardino, California, United States

Saint Louis University

St Louis, Missouri, United States