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

S

Saint Louis University (SLU)

Status

Active, not recruiting

Conditions

Kidney Transplant; Complications
DGF

Treatments

Diagnostic Test: Highly suppressive Treg measurement

Study type

Observational

Funder types

Other

Identifiers

NCT04414111
30530

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

180 participants in 1 patient group

Kidney transplant recipient
Description:
Kidney transplant recipient
Treatment:
Diagnostic Test: Highly suppressive Treg measurement

Trial contacts and locations

2

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Central trial contact

Henry Randall, MD

Data sourced from clinicaltrials.gov

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