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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04414111

Enrollment

180

Registered

2020-06-04

Start date

2020-12-07

Completion date

2027-07-31

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DGF, Kidney Transplant; Complications

Keywords

DGF, SGF, Acute rejection, Kidney transplantation

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.

Interventions

DIAGNOSTIC_TESTHighly suppressive Treg measurement

Circulating highly suppressive Treg measurement

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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
Delayed graft function	1 week	Delayed graft function defined as dialysis requirement within the first week after kidney transplant

Secondary

Measure	Time frame	Description
Acute rejection	1 year	Kidney allograft biopsy-proven acute rejection according to Banff criteria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026