RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Integration of Donor-derived Cell-free DNA With HLA-DR+TNFR2+ Regulatory T Cell in the Prediction of Acute Rejection and Graft Function After Kidney Transplantation

Quick Facts

Study Start:2020-12-07
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05084768

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult kidney transplant candidates/recipients
  1. * Age less than 18
  2. * Multi-organ transplants
  3. * Kidney transplant candidates/recipients with HIV
  4. * Kidney transplant candidates/recipients with HCV

Contacts and Locations

Study Contact

Ryan Evans, CCRP
CONTACT
9095583870
rlevans@llu.edu

Principal Investigator

Minh-Tri Nguyen, MD PhD
PRINCIPAL_INVESTIGATOR
Loma Linda University

Study Locations (Sites)

Loma Linda University Health
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Minh-Tri Nguyen, MD PhD, PRINCIPAL_INVESTIGATOR, Loma Linda University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-07
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2020-12-07
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Rejection of Renal Transplant
  • Graft Failure