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

Study Overview
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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.

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

Conditions
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DGF, Kidney Transplant; Complications

Intervention / Treatment
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* Diagnostic Test: Highly suppressive Treg measurement


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney transplant recipient<br>Kidney transplant recipient | Diagnostic Test: Highly suppressive Treg measurement<br>* Circulating highly suppressive Treg measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute rejection, DGF, SGF, Kidney transplantation