Kidney Transplant RejectionNCT07060716
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
An observational study of Kidney Transplant Rejection and Cell-free DNA, run by Insight Molecular Diagnostics at 10 sites in 2 countries.
Trial summary
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection, Cell-free DNA
- What is being tested?
- donor-derived cell-free DNA test
- How many people
- 125 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 8 Sep 2025to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have received a kidney transplant at centers in the United States and Germany will be invited to participate.
Who may be able to join
- Subject is 18 years of age or older
- At least 12 calendar days have elapsed since the subject received a kidney transplant.
- Subject has provided legally effective informed consent
- Subject agrees to comply with all study procedures
Who cannot join
- Kidney donor is an identical twin of the subject.
- The subject has another previously transplanted organ in situ.
- Subject has received a hematopoietic stem cell transplant.
- Subject has received a bone marrow graft.
- Subject has self-reported as pregnant.
- In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.
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- Sample Inclusion Criteria:
- 1. A graft biopsy is obtained within ±1 week of blood draw.
- If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.
- Sample Exclusion Criteria:
- Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
- Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
- Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
- Sample collected from a subject that provided another sample for the study within the past 7 days.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States8 sites, 6 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Jennifer Seaman-Czerr, 216-990-0436, Czerrj@ccf.org
Ziad Zaky, MD
- Recruiting
Baylor, Scott & White Research Institute
Dallas, Texas, 75246
Eric Javier Martinez, MD, 214-820-2050, Eric.Martinez1@BSWHealth.org
Ashley McAllister, 214-820-1710, Ashley.McAllister@BSWHealth.org
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Carla Palmucci, 904-953-3182, Palmucci.Carla@mayo.edu
Mohamed Elrefaei, MD, PhD
- Active, not recruiting
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
- Recruiting
Intermountain Health
Murray, Utah, 84107
Shannon Sell, 801-507-8390, Shannon.sell@imail.org
Sanjiv Anand, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Keyann Reaves, 615-936-0695, Keyann.d.reaves@vumc.org
Anthony Langone, MD
- Active, not recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Anelys Marin, B.S., 813-844-2673, research@tgh.org
Sandra Sanchez, slsanchez@tgh.org
Germany2 sites
- Active, not recruiting
Charite Universitatsmedizin
Berlin, 10117
- Active, not recruiting
Institute of Immunology - Transplantation Immunology
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.
- Conditions
- Kidney Transplant Rejection, Cell-free DNA
- Being tested
- donor-derived cell-free DNA test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor-derived cell-free DNA testDiagnostic test
A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Relative percentage of dd-cfDNA levels of 0.5% and absolute values of 50cp/mL are considered to be the diagnostic cutoff for rejection, which will be refined during the first study phase.
Measured: Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Clinical sensitivity of the dd-cfDNA test shall be better or equal to published values (≥56%). Current literature shows an average sensitivity of 69% with a SD of 13%. Therefore, 56% represents the lower boundary (average - 1SD) of the distribution of published values.
Measured: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Clinical Specificity of the dd-cfDNA test shall be better or equal to published values (≥75%). Current literature shows an average specificity of 81% with a SD of 6%. Therefore, 75% represents the lower boundary (average - 1SD) of the distribution of published values.
Measured: Samples tested after the assay final cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for NPV is 85%.
Measured: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for Positive Predictive Value (PPV) is 49%.
Measured: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Secondary outcomes (2)
ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection.
The second endpoint is for investigational use only and therefore has no predefined success criteria.
Measured: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.
Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen).
The second endpoint is for investigational use only and therefore has no predefined success criteria.
Measured: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start8 Sep 2025
- Primary completion30 Nov 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insight Molecular Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekkehard Schuetz, MD, PhD, Study chair, Insight Molecular Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060716
- Sponsor's protocol ID
- CLN-001
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
- ClinicalTrials.gov ID
- NCT07060716
- Acronym / sponsor ID
- CLN-001
- Conditions
- Kidney Transplant Rejection, Cell-free DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Insight Molecular DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jul 2025 (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.
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have received a kidney transplant at centers in the United States and Germany will be invited to participate.
Key inclusion criteria (4 listed)
- Subject is 18 years of age or older
- At least 12 calendar days have elapsed since the subject received a kidney transplant.
- Subject has provided legally effective informed consent
- Subject agrees to comply with all study procedures
Key exclusion criteria (14 listed)
- Kidney donor is an identical twin of the subject.
- The subject has another previously transplanted organ in situ.
- Subject has received a hematopoietic stem cell transplant.
- Subject has received a bone marrow graft.
- Subject has self-reported as pregnant.
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 |
|---|---|---|
| donor-derived cell-free DNA testA donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA. | Diagnostic test | – |
Primary outcome
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Time frame: Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples.
Relative percentage of dd-cfDNA levels of 0.5% and absolute values of 50cp/mL are considered to be the diagnostic cutoff for rejection, which will be refined during the first study phase.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Time frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Clinical sensitivity of the dd-cfDNA test shall be better or equal to published values (≥56%). Current literature shows an average sensitivity of 69% with a SD of 13%. Therefore, 56% represents the lower boundary (average - 1SD) of the distribution of published values.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Time frame: Samples tested after the assay final cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Clinical Specificity of the dd-cfDNA test shall be better or equal to published values (≥75%). Current literature shows an average specificity of 81% with a SD of 6%. Therefore, 75% represents the lower boundary (average - 1SD) of the distribution of published values.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Time frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for NPV is 85%.
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Time frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.
Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for Positive Predictive Value (PPV) is 49%.
2 secondary outcomes
ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection.
Time frame: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.
Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen).
Time frame: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.
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 19 Nov 2025.
- Individual participant dataSharing planned: Undecided. only IPD used in the results publication
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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.
Ekkehard Schuetz, MD, PhD study chair
Insight Molecular Diagnostics
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Rejection and Cell-free DNA, run by Insight Molecular Diagnostics at 10 sites in 2 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 19 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 10 sites in United States, Germany. 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?
Contact Robert Rogers, M.S. (14436258427, rrogers@imdxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection (time frame: Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples.). The study lists 5 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 19 Nov 2025.