Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA

NCT07415876 | Recruiting

• 1 other identifier: HM300000312
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney transplant rejection remains a significant challenge to long-term graft survival. While histological biopsy continues to be the gold standard for diagnosing rejection, noninvasive biomarkers such as donor-derived cell-free DNA (dd-cfDNA) have gained traction for their ability to detect allograft injury. However, dd-cfDNA may lack sensitivity in certain clinical scenarios particularly in cases of localized immune activation leading to false negatives despite biopsy-confirmed rejection.

Conditions

Kidney Transplant Rejection

Keywords

CXCL10; CXCR3+T cells; ccfDNA; dd-cfDNA; ABMR; TCMR

Outcome Measures

Primary Outcomes (2)

• Assess urinary CXCL10 compared to dd-cfDNA for diagnosing acute rejection in kidney transplant recipients

  Assess whether urinary CXCL10 concentration (pg/mL) demonstrates improved sensitivity compared to donor-derived cell-free DNA (dd-cfDNA) for diagnosing acute rejection in kidney transplant recipients, specifically among discordant cases with biopsy-confirmed rejection and dd-cfDNA levels below 1%. Urine sample collected prospectively, during clinically indicated biopsy visit. Urine sample collected retrospectively, during clinically indicated retrospective biopsy visit.

  From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.

• Assess the stability of urinary CXCL10 under different transport conditions

  Assess the stability of urinary CXCL10 (percent recovery) under different transport conditions-refrigerated, and ambient (room temperature)-to determine whether ambient shipping is a viable alternative to cold-chain transport for clinical testing. Urine sample collected prospectively, during clinically indicated biopsy visit. Urine sample collected retrospectively, during clinically indicated retrospective biopsy visit.

  From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.

Secondary Outcomes (3)

• Compare urinary CXCL10 concentrations to assess potential degradation or variability.

  From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.

• Determine whether ambient shipping (urine sample) affects the clinical reliability of CXCL10 measurements

  From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.

• Assess the feasibility of implementing ambient (urine sample) shipping as a cost-effective alternative

  From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.

Study Arms (2)

Retrospective (Kidney Transplant recipients)

There will be 20 Retrospective (Kidney Transplant recipients) subjects enrolled

Other: Retrospective Cohort Enrollment

Prospective (Kidney Transplant recipients)

There will be 30 Prospective (Kidney Transplant recipients) subjects enrolled

Other: Prospective Cohort Enrollment

Interventions

Retrospective Cohort Enrollment OTHER

Subjects for this cohort will be selected from existing research database and criteria include: hx of kidney transplantation, clinically indicated biopsy, positive histology, \<1% circulating donor-derived cell-free DNA (dd-cfDNA) result at the time of biopsy, and Availability of frozen urine samples.

Retrospective (Kidney Transplant recipients)

Prospective Cohort Enrollment OTHER

Subjects for this cohort will be selected based on ability to provide urine sample, recent kidney transplant recipient and underwent a clinically indicated biopsy

Prospective (Kidney Transplant recipients)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 50 kidney transplant recipients will be included in this study: * 20 retrospective subjects: will be selected from the HM20019578 VCU Kidney Transplant Prospective Registry. These individuals have biopsy-confirmed acute rejection with dd-cfDNA\<1% results. Frozen urine aliquots previously biobanked from these subjects will be used for CXCL10 testing. * 30 prospective subjects: will be enrolled at the time of a clinically indicated kidney biopsy. A single urine sample will be collected during the biopsy visit and immediately split into two equal aliquots. One aliquot will be stored and transported under refrigerated conditions, while the other will be kept under ambient conditions. Both samples will be shipped simultaneously to One Lambda for CXCL10 testing.

You may qualify if:

• Age ≥18 years
• Undergoing a clinically indicated biopsy
• Able to provide informed consent
• Willing to provide a urine sample and allow access to relevant clinical
• Age ≥18 years
• Biopsy-confirmed rejection (positive histology)
• Donor-derived cell-free DNA\<1% result at time of biopsy
• Availability of stored urine sample collected at time of biopsy

You may not qualify if:

• Individuals under 18 years of age
• Individuals unable to provide informed consent (for prospective enrollment)
• Pregnant women
• Prisoners
• Adults unable to consent

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Thermo Fisher Scientific, Inc: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• Gaurav Gupta, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber Paulus, PhD

CONTACT

(804) 628-4969; amber.Paulus@vcuhealth.org

Gelila Abebe

CONTACT

gelila.abebe@vcuhealth.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)