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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLoma Linda University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult kidney transplant candidates/recipients

Disqualifiers

Age less than 18

Multi-organ transplants

Kidney transplant candidates/recipients with HIV

Kidney transplant candidates/recipients with HCV

Trial population

Adult kidney transplant candidates/recipients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Donor-derived cell-free DNA

    Diagnostic test

    As mentioned previously

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Rejection of kidney transplant1 intervention
Group B: No rejection of kidney transplant1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with biopsy-proven acute rejection graded with the Banff score

TCMR 1A, TCMR 1B, TCMR 2A, TCMR 2B, TCMR 3B, ABMR

Time frame
1 year

Secondary outcomes

1

Number of participants with graft failure based on return to chronic dialysis or death

Return to chronic dialysis, Death

Time frame
1 year

Other outcomes

Sponsors and contacts

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