Kidney TransplantGALACTICNCT07551531
GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial
An observational study of Kidney Transplant, run by Insight Molecular Diagnostics at 1 site in United States.
Trial summary
The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure (GraftAssureCore and GraftAssureDx) assay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2033
- How long will I take part?
- 3 Years
- 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: Adult kidney transplant recipients across up to 60 student centers in the United States.
Who may be able to join
- 18 years of age or older.
- ≥ 2 weeks post-kidney transplant at the time of first sample collection.
- Provides legally effective informed consent.
- Agrees to comply with all study procedures.
- 18 years of age or older
- Has a minimum of three clinical evaluations per year post-transplant.
Who cannot join
- Has received transplanted kidney from their identical twin.
- Has a history of another previously transplanted organ in situ, other than a prior kidney transplant.
- Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT).
- Self-reports as pregnant.
- Has a current malignancy, other than low-grade malignancy.
- Actively enrolled in another cfDNA assay-based trial.
Show all 11Show fewer
- In the opinion of the investigator, participation in this study would pose a risk to data integrity or to the participant's safety and welfare.
- Has received a kidney transplant from their identical twin.
- Has a history of another previously transplanted organ in situ, excluding previous kidney transplant.
- Has a current malignancy, other than low-grade malignancy.
- Self-reported pregnancy during the historical data time period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haley Russell contact
United States1 site
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Ana Merced Director of Transplant Services, PhD, MSN, RN, BS, CCTC, 973-322-8467, Ana.Merced@rwjbh.org
Anup Patel, MD
About this study
Official title: GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status
The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure (GraftAssureCore and GraftAssureDx) assay. This will also be correlated with the biopsy yield and treatment decisions. The GraftAssure assay is a diagnostic test intended for the quantitative measurement of dd-cfDNA in plasma from kidney transplant recipients. The test is minimally invasive, and is intended to be used in conjunction with standard clinical assessment and other laboratory findings as an aid in the detection of allograft rejection.
Read the detailed description
This is a prospective, multi-center, longitudinal, registry study.
The study will be conducted in two parts:
Part 1: GraftAssureCore assay (Laboratory-Developed Test)
Blood samples will be obtained by the site, or via contracted phlebotomy or laboratory services, and shipped to iMDx for centralized GraftAssure testing. Results will be reported to the study site.
Part 2: GraftAssureDx assay (On-Site Testing at study site)
Sites will be trained to perform on-site GraftAssure testing in-house with iMDx permission, post-FDA authorization.
- Conditions
- Kidney Transplant
- Keywords
- kidney transplant, dd-cfDNA, cell-free DNA, allograft rejection, donor derived cell-free DNA, kidney rejection, rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant recipients | Adult kidney transplant recipients at least 2 weeks post-kidney transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect Rejection
Detection of rejection using fractional abundance (%) dd-cfDNA, absolute (cp/mL) dd-cfDNA, and a Combination Model-score of both of these values.
Measured: 7 years
Validate Superiority of Combination Model-score (CM-score)
Validate superiority of combined use of percent \& cp/mL dd-cfDNA values, defined as Combination Model-score, over individual dd-cfDNA percent and cp/mL values.
Measured: 7 years
Secondary outcomes (4)
Association of dd-cfDNA levels
Association of dd-cfDNA levels and graft survival/retained function, retransplant, DSA development, and patient survival.
Measured: 7 years
Graft survival
Graft survival
Measured: 7 years
Biopsy rate and yield
Measured: 7 years
Time-to-intervention impact
Lower hospitalization rates, less severe rejection, lower treatment intensity.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies 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
- 5,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Insight Molecular Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551531
- Sponsor's protocol ID
- GAL-001
- Acronym
- GALACTIC
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: only IPD used in the results publication
Publications
Benning L, Akifova A, Oellerich M, Osmanodja B, Morath C, Beck J, Schuetz A, Bornemann-Kolatzki K, Schrezenmeier EV, Tran TH, Schwenger V, Shipkova M, Wieland E, Schuetz E, Budde K. Improving diagnostic performance of kidney allograft rejection with a model combining relative fraction and absolute copies of donor-derived cell-free DNA-Results from 5 independent cohorts. Am J Transplant. 2026 Jun 10:S1600-6135(26)02586-4. doi: 10.1016/j.ajt.2026.06.004. Online ahead of print.
PubMed 42269874Huang Y, Farkash E. Protocol Biopsies: Utility and Limitations. Adv Chronic Kidney Dis. 2016 Sep;23(5):326-331. doi: 10.1053/j.ackd.2016.09.002.
PubMed 27742388Khush K, Hall S, Kao A, Raval N, Dhingra R, Shah P, Bellumkonda L, Ravichandran A, Van Bakel A, Uriel N, Patel S, Pinney S, DePasquale E, Baran DA, Pinney K, Oreschak K, Kobulnik J, Shen L, Teuteberg J. Surveillance with dual noninvasive testing for acute cellular rejection after heart transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry. J Heart Lung Transplant. 2024 Sep;43(9):1409-1421. doi: 10.1016/j.healun.2024.05.003. Epub 2024 May 15.
PubMed 38759766Halloran PF, Reeve J, Madill-Thomsen KS, Kaur N, Ahmed E, Cantos C, Al Haj Baddar N, Demko Z, Liang N, Swenerton RK, Zimmermann BG, Van Hummelen P, Prewett A, Rabinowitz M, Tabriziani H, Gauthier P, Billings P; Trifecta Investigators*. Combining Donor-derived Cell-free DNA Fraction and Quantity to Detect Kidney Transplant Rejection Using Molecular Diagnoses and Histology as Confirmation. Transplantation. 2022 Dec 1;106(12):2435-2442. doi: 10.1097/TP.0000000000004212. Epub 2022 Nov 22.
PubMed 35765145Akifova A, Budde K, Choi M, Oellerich M, Beck J, Bornemann-Kolatzki K, Schutz E, Kowald J, Osmanodja B. Donor-Derived Cell-Free DNA in Biopsy-Proven Antibody-Mediated Rejection Versus Recurrent IgA Nephropathy After Kidney Transplantation. Kidney Int Rep. 2023 Jul 21;8(10):2141-2145. doi: 10.1016/j.ekir.2023.07.011. eCollection 2023 Oct. No abstract available.
PubMed 37849995Oellerich M, Shipkova M, Asendorf T, Walson PD, Schauerte V, Mettenmeyer N, Kabakchiev M, Hasche G, Grone HJ, Friede T, Wieland E, Schwenger V, Schutz E, Beck J. Absolute quantification of donor-derived cell-free DNA as a marker of rejection and graft injury in kidney transplantation: Results from a prospective observational study. Am J Transplant. 2019 Nov;19(11):3087-3099. doi: 10.1111/ajt.15416. Epub 2019 May 28.
PubMed 31062511Beck J, Bierau S, Balzer S, Andag R, Kanzow P, Schmitz J, Gaedcke J, Moerer O, Slotta JE, Walson P, Kollmar O, Oellerich M, Schutz E. Digital droplet PCR for rapid quantification of donor DNA in the circulation of transplant recipients as a potential universal biomarker of graft injury. Clin Chem. 2013 Dec;59(12):1732-41. doi: 10.1373/clinchem.2013.210328. Epub 2013 Sep 23.
PubMed 24061615Bu L, Gupta G, Pai A, Anand S, Stites E, Moinuddin I, Bowers V, Jain P, Axelrod DA, Weir MR, Wolf-Doty TK, Zeng J, Tian W, Qu K, Woodward R, Dholakia S, De Golovine A, Bromberg JS, Murad H, Alhamad T. Clinical outcomes from the Assessing Donor-derived cell-free DNA Monitoring Insights of kidney Allografts with Longitudinal surveillance (ADMIRAL) study. Kidney Int. 2022 Apr;101(4):793-803. doi: 10.1016/j.kint.2021.11.034. Epub 2021 Dec 22.
PubMed 34953773Hysi K, Foster K. (2024) Trends in dd-cfDNA in Kidney Transplant Patients Converted from Tacrolimus to Belatacept for Immunosuppression Maintenance [abstract]. In: American Transplant Congress; 2024 June 1-5; Philadelphia, (PA). NYU Langone Health, New York, NY; Abstract nr C343.
Turgut D, Kendi ZK, Handan O, et al. (2020). How Calcineurin Inhibitor Dosage and Blood Trough Levels Affect Kidney Allograft Survival? Transplantation 104(S3):p S437.
Farouk SS, Rein JL. The Many Faces of Calcineurin Inhibitor Toxicity-What the FK? Adv Chronic Kidney Dis. 2020 Jan;27(1):56-66. doi: 10.1053/j.ackd.2019.08.006.
PubMed 32147003Osmanodja B, Akifova A, Oellerich M, Beck J, Bornemann-Kolatzki K, Schutz E, Budde K. Donor-Derived Cell-Free DNA for Kidney Allograft Surveillance after Conversion to Belatacept: Prospective Pilot Study. J Clin Med. 2023 Mar 22;12(6):2437. doi: 10.3390/jcm12062437.
PubMed 36983437Osmanodja B, Akifova A, Budde K, Oellerich M, Beck J, Bornemann-Kolatzki K, Schutz E, Velden J, Lehmann C, Kruger BM, Bachmann A, Kowald J. Donor-Derived Cell-Free DNA as a Companion Biomarker for AMR Treatment With Daratumumab: Case Series. Transpl Int. 2024 Aug 1;37:13213. doi: 10.3389/ti.2024.13213. eCollection 2024.
PubMed 39149569Mayer KA, Schrezenmeier E, Diebold M, Halloran PF, Schatzl M, Schranz S, Haindl S, Kasbohm S, Kainz A, Eskandary F, Doberer K, Patel UD, Dudani JS, Regele H, Kozakowski N, Klager J, Boxhammer R, Amann K, Puchhammer-Stockl E, Vietzen H, Beck J, Schutz E, Akifova A, Firbas C, Gilbert HN, Osmanodja B, Halleck F, Jilma B, Budde K, Bohmig GA. A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection. N Engl J Med. 2024 Jul 11;391(2):122-132. doi: 10.1056/NEJMoa2400763. Epub 2024 May 25.
PubMed 38804514Akifova A, Budde K, Amann K, Buettner-Herold M, Choi M, Oellerich M, Beck J, Bornemann-Kolatzki K, Schutz E, Bachmann F, Halleck F, von Hoerschelmann E, Koch N, Schrezenmeier E, Seelow E, Waiser J, Zukunft B, Eckardt KU, Halbritter J, Kettritz R, Del Moral CL, Lachmann N, Stauch D, Niemann M, Schmidt D, Halloran PF, Osmanodja B. Donor-derived cell-free DNA monitoring for early diagnosis of antibody-mediated rejection after kidney transplantation: a randomized trial. Nephrol Dial Transplant. 2025 Jun 30;40(7):1384-1395. doi: 10.1093/ndt/gfae282.
PubMed 39673311
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status
- ClinicalTrials.gov ID
- NCT07551531
- Acronym / sponsor ID
- GALACTIC / GAL-001
- Conditions
- Kidney Transplant
- Keywords
- kidney transplant, dd-cfDNA, cell-free DNA, allograft rejection, donor derived cell-free DNA, kidney rejection, rejection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Insight Molecular DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 27 Apr 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.
The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure (GraftAssureCore and GraftAssureDx) assay. This will also be correlated with the biopsy yield and treatment decisions. The GraftAssure assay is a diagnostic test intended for the quantitative measurement of dd-cfDNA in plasma from kidney transplant recipients. The test is minimally invasive, and is intended to be used in conjunction with standard clinical assessment and other laboratory findings as an aid in the detection of allograft rejection.
Detailed description
This is a prospective, multi-center, longitudinal, registry study.
The study will be conducted in two parts:
Part 1: GraftAssureCore assay (Laboratory-Developed Test)
Blood samples will be obtained by the site, or via contracted phlebotomy or laboratory services, and shipped to iMDx for centralized GraftAssure testing. Results will be reported to the study site.
Part 2: GraftAssureDx assay (On-Site Testing at study site)
Sites will be trained to perform on-site GraftAssure testing in-house with iMDx permission, post-FDA authorization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant recipients | – | –Adult kidney transplant recipients at least 2 weeks post-kidney transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney transplant recipients across up to 60 student centers in the United States.
Key inclusion criteria (6 listed)
- 18 years of age or older.
- ≥ 2 weeks post-kidney transplant at the time of first sample collection.
- Provides legally effective informed consent.
- Agrees to comply with all study procedures.
- 18 years of age or older
Key exclusion criteria (11 listed)
- Has received transplanted kidney from their identical twin.
- Has a history of another previously transplanted organ in situ, other than a prior kidney transplant.
- Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT).
- Self-reports as pregnant.
- Has a current malignancy, other than low-grade malignancy.
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
Detect Rejection
Time frame: 7 years
Detection of rejection using fractional abundance (%) dd-cfDNA, absolute (cp/mL) dd-cfDNA, and a Combination Model-score of both of these values.
Validate Superiority of Combination Model-score (CM-score)
Time frame: 7 years
Validate superiority of combined use of percent \& cp/mL dd-cfDNA values, defined as Combination Model-score, over individual dd-cfDNA percent and cp/mL values.
4 secondary outcomes
Association of dd-cfDNA levels
Time frame: 7 years
Graft survival
Time frame: 7 years
Biopsy rate and yield
Time frame: 7 years
Time-to-intervention impact
Time frame: 7 years
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 30 Jul 2026.
- Background: PubMed 42269874Benning L, Akifova A, Oellerich M, Osmanodja B, Morath C, Beck J, Schuetz A, Bornemann-Kolatzki K, Schrezenmeier EV, Tran TH, Schwenger V, Shipkova M, Wieland E, Schuetz E, Budde K. Improving diagnostic performance of kidney allograft rejection with a model combining relative fraction and absolute copies of donor-derived cell-free DNA-Results from 5 independent cohorts. Am J Transplant. 2026 Jun 10:S1600-6135(26)02586-4. doi: 10.1016/j.ajt.2026.06.004. Online ahead of print.
- Background: PubMed 27742388Huang Y, Farkash E. Protocol Biopsies: Utility and Limitations. Adv Chronic Kidney Dis. 2016 Sep;23(5):326-331. doi: 10.1053/j.ackd.2016.09.002.
- Background: PubMed 38759766Khush K, Hall S, Kao A, Raval N, Dhingra R, Shah P, Bellumkonda L, Ravichandran A, Van Bakel A, Uriel N, Patel S, Pinney S, DePasquale E, Baran DA, Pinney K, Oreschak K, Kobulnik J, Shen L, Teuteberg J. Surveillance with dual noninvasive testing for acute cellular rejection after heart transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry. J Heart Lung Transplant. 2024 Sep;43(9):1409-1421. doi: 10.1016/j.healun.2024.05.003. Epub 2024 May 15.
- Background: PubMed 35765145Halloran PF, Reeve J, Madill-Thomsen KS, Kaur N, Ahmed E, Cantos C, Al Haj Baddar N, Demko Z, Liang N, Swenerton RK, Zimmermann BG, Van Hummelen P, Prewett A, Rabinowitz M, Tabriziani H, Gauthier P, Billings P; Trifecta Investigators*. Combining Donor-derived Cell-free DNA Fraction and Quantity to Detect Kidney Transplant Rejection Using Molecular Diagnoses and Histology as Confirmation. Transplantation. 2022 Dec 1;106(12):2435-2442. doi: 10.1097/TP.0000000000004212. Epub 2022 Nov 22.
- Background: PubMed 37849995Akifova A, Budde K, Choi M, Oellerich M, Beck J, Bornemann-Kolatzki K, Schutz E, Kowald J, Osmanodja B. Donor-Derived Cell-Free DNA in Biopsy-Proven Antibody-Mediated Rejection Versus Recurrent IgA Nephropathy After Kidney Transplantation. Kidney Int Rep. 2023 Jul 21;8(10):2141-2145. doi: 10.1016/j.ekir.2023.07.011. eCollection 2023 Oct. No abstract available.
- Background: PubMed 31062511Oellerich M, Shipkova M, Asendorf T, Walson PD, Schauerte V, Mettenmeyer N, Kabakchiev M, Hasche G, Grone HJ, Friede T, Wieland E, Schwenger V, Schutz E, Beck J. Absolute quantification of donor-derived cell-free DNA as a marker of rejection and graft injury in kidney transplantation: Results from a prospective observational study. Am J Transplant. 2019 Nov;19(11):3087-3099. doi: 10.1111/ajt.15416. Epub 2019 May 28.
- Background: PubMed 24061615Beck J, Bierau S, Balzer S, Andag R, Kanzow P, Schmitz J, Gaedcke J, Moerer O, Slotta JE, Walson P, Kollmar O, Oellerich M, Schutz E. Digital droplet PCR for rapid quantification of donor DNA in the circulation of transplant recipients as a potential universal biomarker of graft injury. Clin Chem. 2013 Dec;59(12):1732-41. doi: 10.1373/clinchem.2013.210328. Epub 2013 Sep 23.
- Background: PubMed 34953773Bu L, Gupta G, Pai A, Anand S, Stites E, Moinuddin I, Bowers V, Jain P, Axelrod DA, Weir MR, Wolf-Doty TK, Zeng J, Tian W, Qu K, Woodward R, Dholakia S, De Golovine A, Bromberg JS, Murad H, Alhamad T. Clinical outcomes from the Assessing Donor-derived cell-free DNA Monitoring Insights of kidney Allografts with Longitudinal surveillance (ADMIRAL) study. Kidney Int. 2022 Apr;101(4):793-803. doi: 10.1016/j.kint.2021.11.034. Epub 2021 Dec 22.
- BackgroundHysi K, Foster K. (2024) Trends in dd-cfDNA in Kidney Transplant Patients Converted from Tacrolimus to Belatacept for Immunosuppression Maintenance [abstract]. In: American Transplant Congress; 2024 June 1-5; Philadelphia, (PA). NYU Langone Health, New York, NY; Abstract nr C343.
- BackgroundTurgut D, Kendi ZK, Handan O, et al. (2020). How Calcineurin Inhibitor Dosage and Blood Trough Levels Affect Kidney Allograft Survival? Transplantation 104(S3):p S437.
- Background: PubMed 32147003Farouk SS, Rein JL. The Many Faces of Calcineurin Inhibitor Toxicity-What the FK? Adv Chronic Kidney Dis. 2020 Jan;27(1):56-66. doi: 10.1053/j.ackd.2019.08.006.
- Background: PubMed 36983437Osmanodja B, Akifova A, Oellerich M, Beck J, Bornemann-Kolatzki K, Schutz E, Budde K. Donor-Derived Cell-Free DNA for Kidney Allograft Surveillance after Conversion to Belatacept: Prospective Pilot Study. J Clin Med. 2023 Mar 22;12(6):2437. doi: 10.3390/jcm12062437.
- 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.
Haley Russell contact
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, run by Insight Molecular Diagnostics 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 30 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?
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 Annum Zhara, MSc. (1-949-554-4946, azhara@imdxinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect Rejection (time frame: 7 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?
On the ClinicalTrials.gov record for NCT07551531, which also lists 20 linked publications.
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 30 Jul 2026.