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

NCT04414111 | Active Not Recruiting DMC

• 1 other identifier: 30530
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

DGF; Kidney Transplant; Complications

Keywords

DGF; SGF; Acute rejection; Kidney transplantation

Outcome Measures

Primary Outcomes (2)

• Delayed graft function

  Delayed graft function defined as dialysis requirement within the first week after kidney transplant

  1 week

• Slow graft function

  Slow graft function defined as a serum creatinine drop of less than 20% in the first 24 hours after kidney transplant

  24 hours

Secondary Outcomes (1)

• Acute rejection

  1 year

Study Arms (1)

Kidney transplant recipient

Kidney transplant recipient

Diagnostic Test: Highly suppressive Treg measurement

Interventions

Highly suppressive Treg measurement DIAGNOSTIC_TEST

Circulating highly suppressive Treg measurement

Kidney transplant recipient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients

You may qualify if:

• \- Adult kidney transplant candidates immediately prior to their kidney transplant surgery

You may not qualify if:

• \< 18 years old
• Active immunosuppressive drug use
• Hepatitis C
• HIV

Sponsors & Collaborators

• St. Louis University: lead
• Mid-America Transplant: collaborator

Study Sites (2)

Loma Linda University Health Transplantation Institute

San Bernardino, California, 92408, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Study Officials

• Henry Randall, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: December 7, 2020
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (2)