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OpenTrials
Active, Not Recruiting

NCT Number: NCT04414111

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Health Transplantation Institute, San Bernardino, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Highly suppressive Treg measurement

Diagnostic Test

Circulating highly suppressive Treg measurement

Primary outcomes

  1. Delayed graft function

    Time frame: 1 week

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

  2. Slow graft function

    Time frame: 24 hours

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

Secondary outcomes

  1. Acute rejection

    Time frame: 1 year

    Kidney allograft biopsy-proven acute rejection according to Banff criteria

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Collaborators

  • Mid-America Transplant

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 4, 2020
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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