Kidney Transplant RejectionNCT07415876
Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA
An observational study of Kidney Transplant Rejection, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Retrospective Cohort Enrollment and Prospective Cohort Enrollment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Individuals under 18 years of age
- Individuals unable to provide informed consent (for prospective enrollment)
- Pregnant women
- Prisoners
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA: Diagnostic Performance and Transport Stability Across Shipping Conditions (CLEAR-CXCL10)
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.
Read the detailed description
One promising biomarker is CXCL10 (C-X-C motif chemokine ligand 10), a chemokine induced by interferon-γ that plays a central role in recruiting CXCR3+ T cells during immune responses. A 2021 study by Arnau et al. found that urinary CXCL10 levels were significantly associated with Banff scores of acute graft injury and donor-specific antibodies, and could discriminate both T-cell-mediated and antibody-mediated rejection in kidney transplant recipients, identifying CXCL10 as a promising candidate non-invasive biomarker for monitoring allograft rejection.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Retrospective Cohort Enrollment, Prospective Cohort Enrollment
- Keywords
- CXCL10, CXCR3+T cells, ccfDNA, dd-cfDNA, ABMR, TCMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective Cohort EnrollmentOther
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.
Prospective Cohort EnrollmentOther
Subjects for this cohort will be selected based on ability to provide urine sample, recent kidney transplant recipient and underwent a clinically indicated biopsy
| Study group | Role | What they receive |
|---|---|---|
| Retrospective (Kidney Transplant recipients) | There will be 20 Retrospective (Kidney Transplant recipients) subjects enrolled Receives: Other: Retrospective Cohort Enrollment | |
| Prospective (Kidney Transplant recipients) | There will be 30 Prospective (Kidney Transplant recipients) subjects enrolled Receives: Other: Prospective Cohort Enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Compare urinary CXCL10 concentrations across the two transport conditions to assess potential degradation or variability.
- Mean absolute difference (pg/mL)
- Coefficient of variation (CV)
- Bland-Altman plots to assess agreement Urine sample collected prospectively, during clinically indicated biopsy visit. Urine sample collected retrospectively, during clinically indicated retrospective biopsy visit.
Measured: 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
Determine whether ambient shipping (urine sample) affects the clinical reliability of CXCL10 measurements
- CXCL10 results dichotomized using predefined clinical thresholds
- Percent agreement and Cohen's kappa statistic calculated between transport conditions
Urine sample collected prospectively, during clinically indicated biopsy visit. Urine sample collected retrospectively, during clinically indicated retrospective biopsy visit.
Measured: 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
Assess the feasibility of implementing ambient (urine sample) shipping as a cost-effective alternative to current cold-chain methods.
- Proportion of samples meeting laboratory acceptance criteria
- Shipping duration summarized in hours from collection to laboratory receipt
Urine sample collected prospectively, during clinically indicated biopsy visit. Urine sample collected retrospectively, during clinically indicated retrospective biopsy visit.
Measured: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start4 Jun 2026
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor
- Investigators
- Gaurav Gupta, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415876
- Sponsor's protocol ID
- HM300000312
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA: Diagnostic Performance and Transport Stability Across Shipping Conditions (CLEAR-CXCL10)
- ClinicalTrials.gov ID
- NCT07415876
- Acronym / sponsor ID
- HM300000312
- Conditions
- Kidney Transplant Rejection
- Keywords
- CXCL10, CXCR3+T cells, ccfDNA, dd-cfDNA, ABMR, TCMR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One promising biomarker is CXCL10 (C-X-C motif chemokine ligand 10), a chemokine induced by interferon-γ that plays a central role in recruiting CXCR3+ T cells during immune responses. A 2021 study by Arnau et al. found that urinary CXCL10 levels were significantly associated with Banff scores of acute graft injury and donor-specific antibodies, and could discriminate both T-cell-mediated and antibody-mediated rejection in kidney transplant recipients, identifying CXCL10 as a promising candidate non-invasive biomarker for monitoring allograft rejection.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective (Kidney Transplant recipients) | – | Other: Retrospective Cohort EnrollmentThere will be 20 Retrospective (Kidney Transplant recipients) subjects enrolled |
| Prospective (Kidney Transplant recipients) | – | Other: Prospective Cohort EnrollmentThere will be 30 Prospective (Kidney Transplant recipients) subjects enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Individuals under 18 years of age
- Individuals unable to provide informed consent (for prospective enrollment)
- Pregnant women
- Prisoners
- Adults unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective Cohort EnrollmentSubjects 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. | Other | Retrospective (Kidney Transplant recipients) |
| Prospective Cohort EnrollmentSubjects for this cohort will be selected based on ability to provide urine sample, recent kidney transplant recipient and underwent a clinically indicated biopsy | Other | Prospective (Kidney Transplant recipients) |
Primary outcome
Assess urinary CXCL10 compared to dd-cfDNA for diagnosing acute rejection in kidney transplant recipients
Time frame: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.
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.
Assess the stability of urinary CXCL10 under different transport conditions
Time frame: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.
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.
3 secondary outcomes
Compare urinary CXCL10 concentrations to assess potential degradation or variability.
Time frame: 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
Time frame: 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
Time frame: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaurav Gupta, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess urinary CXCL10 compared to dd-cfDNA for diagnosing acute rejection in kidney transplant recipients (time frame: From date of inclusion until loss of follow-up, graft loss or death assessed up to 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.