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

NCT ID: NCT04414111

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-07

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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DGF Kidney Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney transplant recipient

Kidney transplant recipient

Highly suppressive Treg measurement

Intervention Type DIAGNOSTIC_TEST

Circulating highly suppressive Treg measurement

Interventions

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Highly suppressive Treg measurement

Circulating highly suppressive Treg measurement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mid-America Transplant

OTHER

Sponsor Role collaborator

St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Henry B. Randall, MD, MBA, FACS

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henry Randall, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

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Loma Linda University Health Transplantation Institute

San Bernardino, California, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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30530

Identifier Type: -

Identifier Source: org_study_id