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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04414111
• Other study ID #: 30530
• Status: Active, not recruiting
• Start date: December 7, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• DGF
• Kidney Transplant; Complications

Intervention

Diagnostic Test:
• Highly suppressive Treg measurement
Circulating highly suppressive Treg measurement

Locations

Country	Name	City	State
United States	Saint Louis University	Saint Louis	Missouri
United States	Loma Linda University Health Transplantation Institute	San Bernardino	California

Sponsors (2)

Lead Sponsor	Collaborator
St. Louis University	Mid-America Transplant

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed graft function	Delayed graft function defined as dialysis requirement within the first week after kidney transplant	1 week
Primary	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	Acute rejection	Kidney allograft biopsy-proven acute rejection according to Banff criteria	1 year