Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT05084768
Status
Recruiting
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Conditions

  • Acute Rejection of Renal Transplant
  • Graft Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Donor-derived cell-free DNA — DIAGNOSTIC_TEST
    As mentioned previously

Study Details

Acute rejection after kidney transplantation should ideally be diagnosed prior to immunologic injury in a non-invasive fashion in order to improve long-term graft function. Donor-derived cell-free DNA (ddcfDNA) is a promising method to do so as it is elevated prior to acute rejection and has good predictive performance especially for antibody-mediated and high severity T-cell mediated rejection. Its ability to predict low severity T-cell mediated rejection and future graft function remains equivocal. Regulatory T cells (Tregs) are essential in transplant tolerance by suppressing effector immune responses. Circulating post-transplant highly suppressive HLA-DR+ Tregs were reduced in recipients who developed acute rejection. Preliminary results in a cohort including predominantly low severity T-cell mediated rejection also showed that pre-transplant circulating highly suppressive TNFR2+ Tregs were reduced in and could predict acute rejection. Integrating dd-cfDNA with HLA-DR+TNFR2+ Treg could improve the predictive performance for acute rejection especially of low severity and potentially predict graft function. Plasma dd-cfDNA and HLA-DR+TNFR2+ Tregs will be measured in 150 kidney transplant recipients at scheduled intervals during the first 6 months post-transplant. Predictive accuracy of a model integrating ddcfDNA and HLA-DR+TNFR2+ Treg for acute rejection will be tested using ROC curve analysis and multivariate logistic regression. Predictive accuracy for 1-year graft function will be tested using multivariate linear regression. High predictive performance for acute rejection and graft function using a model integrating dd-cfDNA and HLA-DR+TNFR2+ Treg would help identify kidney transplant recipients at immunologic risk early on and allow personalization of immunosuppression accordingly.

Key Dates

Start date
Dec 7, 2020
Status verified
Aug 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Rejection of kidney transplant
    Diagnostic test: measurement of regulatory T cell and donor-derived cell-free DNA
  • Arm: No rejection of kidney transplant
    Diagnostic test: measurement of regulatory T cell and donor-derived cell-free DNA

Primary Outcome Measure

Number of participants with biopsy-proven acute rejection graded with the Banff score [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loma Linda University HealthLoma LindaCalifornia92354-

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