Kidney Transplant RejectionNCT04727788
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
An observational study of Kidney Transplant Rejection, run by Verici Dx at 13 sites in 4 countries.
Trial summary
Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplant Rejection
- How many people
- 550 participants
- Where
- 13 sitesin 4 countries
- Study dates
- 21 Mar 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney or kidney/pancreas transplant patients
Who may be able to join
- Individual Recipients of living or deceased donor kidney transplant
- Age: ≥ 18 ≤ 80
- The subject must be able to comprehend and sign an approved informed consent form
Who cannot join
- Recipients of multiple organ transplant, except kidney-pancreas multiple transplant
- Subjects who are currently participating in a therapeutic clinical trial for transplant rejection
- HIV or Hepatitis C positive patients
- Persons who are known to be pregnant
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States9 sites
University of Maryland
Baltimore, Maryland, 21201
University of Illinois at Chicago
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford
Detroit, Michigan, 48202
Northwestern University
Evanston, Illinois, 60611
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Nebraska Medical Center
Omaha, Nebraska, 68198
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
University of Washington
Seattle, Washington, 98195
About this study
Official title: Validation of Genomic Immune-phenotyping Profiles in Peripheral Blood Gene Signatures to Predict Risk of Kidney Transplant Rejection
Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. cellular / antibody-mediated), rejection and death censored graft loss.
Read the detailed description
The study is correlative and observational and will involve collecting clinical and pathological data along with blood, biopsy tissue and urine during standard routine scheduled medical visits for transplant preparation or monitoring. The blood will be used for next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of three Verici Dx sequencing immune-phenotype signature risk score tests. The research biopsy tissue and urine are for secondary or exploratory objectives. To allow comparison with current accepted standard approaches to identify kidney transplant injury or rejection, digital images of stained tissue sections taken from surveillance or for-cause biopsy tissue will be evaluated in a central pathology laboratory for the purposes of this study. Enrolled subjects will continue in the study for 24 months during which the planned validation of the acute clinical and subclinical rejection tests will complete after 6 months of follow-up; subjects will be followed to 24 months for the validation of the Verici Dx blood-based fibrosis risk prognostic test. After 24 months, patients will be followed through ANZDATA and UNOS registry data for later development of fibrosis or for graft loss or death.
- Conditions
- Kidney Transplant Rejection
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR)
early acute rejection occurring within first 6 months, including borderline ACR
Measured: baseline
Acute Cellular Rejection (ACR): test to identify the risk of clinical and sub-clinical ACR
clinical or subclinical acute rejection 3 months post transplant including borderline ACR, acute cell-mediated rejection as confirmed by histologic evidence on biopsy
Measured: 6 months
Fibrosis: test to predict the risk of developing fibrosis of the allograft and allograft loss
clinical or subclinical acute rejection due to fibrosis 12 months post transplant as confirmed by histologic evidence on biopsy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start21 Mar 2021
- Primary completion31 Mar 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verici Dx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Donovan, PhD, MD, Principal investigator, Verici Dx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727788
- Sponsor's protocol ID
- VDX 20-1001
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Concepcion BP, Bestard O, Samaniego-Picota M, Prashar R, Ansari MJ, Comai G, Gessaroli E, Rostaing L, Alberici F, Mannon RB, Augustine J, Wee A, Poggio E, DiCocco P, Leca N, Shawar S, Bhati C, Maluf D, Rothstein DM, Cherukuri A, Chang A, Salem F, Kattan MW, Schold JD, Connolly P, Rose A, Doshi N, Gallon L, Donovan MJ. A Pre-Kidney Transplant Blood-Based Next-Generation Sequencing Assay to Predict Early Acute Rejection. Kidney360. 2026 Aug 1;7(8):1792-1806. doi: 10.34067/KID.0000001208. Epub 2026 May 14.
PubMed 42133442
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Genomic Immune-phenotyping Profiles in Peripheral Blood Gene Signatures to Predict Risk of Kidney Transplant Rejection
- ClinicalTrials.gov ID
- NCT04727788
- Acronym / sponsor ID
- VDX 20-1001
- Conditions
- Kidney Transplant Rejection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Verici DxIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jan 2021 (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.
Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. cellular / antibody-mediated), rejection and death censored graft loss.
Detailed description
The study is correlative and observational and will involve collecting clinical and pathological data along with blood, biopsy tissue and urine during standard routine scheduled medical visits for transplant preparation or monitoring. The blood will be used for next generation sequencing in the Verici Dx laboratory to create transcriptomic profiles to validate performance characteristics of three Verici Dx sequencing immune-phenotype signature risk score tests. The research biopsy tissue and urine are for secondary or exploratory objectives. To allow comparison with current accepted standard approaches to identify kidney transplant injury or rejection, digital images of stained tissue sections taken from surveillance or for-cause biopsy tissue will be evaluated in a central pathology laboratory for the purposes of this study. Enrolled subjects will continue in the study for 24 months during which the planned validation of the acute clinical and subclinical rejection tests will complete after 6 months of follow-up; subjects will be followed to 24 months for the validation of the Verici Dx blood-based fibrosis risk prognostic test. After 24 months, patients will be followed through ANZDATA and UNOS registry data for later development of fibrosis or for graft loss or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney or kidney/pancreas transplant patients
Key inclusion criteria (3 listed)
- Individual Recipients of living or deceased donor kidney transplant
- Age: ≥ 18 ≤ 80
- The subject must be able to comprehend and sign an approved informed consent form
Key exclusion criteria (4 listed)
- Recipients of multiple organ transplant, except kidney-pancreas multiple transplant
- Subjects who are currently participating in a therapeutic clinical trial for transplant rejection
- HIV or Hepatitis C positive patients
- Persons who are known to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR)
Time frame: baseline
early acute rejection occurring within first 6 months, including borderline ACR
Acute Cellular Rejection (ACR): test to identify the risk of clinical and sub-clinical ACR
Time frame: 6 months
clinical or subclinical acute rejection 3 months post transplant including borderline ACR, acute cell-mediated rejection as confirmed by histologic evidence on biopsy
Fibrosis: test to predict the risk of developing fibrosis of the allograft and allograft loss
Time frame: 24 months
clinical or subclinical acute rejection due to fibrosis 12 months post transplant as confirmed by histologic evidence on biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 42133442Concepcion BP, Bestard O, Samaniego-Picota M, Prashar R, Ansari MJ, Comai G, Gessaroli E, Rostaing L, Alberici F, Mannon RB, Augustine J, Wee A, Poggio E, DiCocco P, Leca N, Shawar S, Bhati C, Maluf D, Rothstein DM, Cherukuri A, Chang A, Salem F, Kattan MW, Schold JD, Connolly P, Rose A, Doshi N, Gallon L, Donovan MJ. A Pre-Kidney Transplant Blood-Based Next-Generation Sequencing Assay to Predict Early Acute Rejection. Kidney360. 2026 Aug 1;7(8):1792-1806. doi: 10.34067/KID.0000001208. Epub 2026 May 14.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant Rejection
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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(TNX-1500) in Kidney Transplant Recipients
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
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Assessment of Perceived Stress in an Observational Study Evaluating a Biopsy-sparing Surveillance Strategy in Kidney Transplant Recipients With Blood and Urinary Biomarkers Predictive of the Absence of Rejection
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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.
Michael J Donovan, PhD, MD principal investigator
Verici Dx
13 sites in 4 countries: 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 Verici Dx at 13 sites in 4 countries.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Italy, France, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pre-transplant: test for prediction of risk of Early Acute Rejection (EAR) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727788, which also lists 1 linked publication.
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 20 Nov 2025.