NCT07551531

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
85mo left

Started Jun 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2033

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

April 15, 2026

Last Update Submit

April 27, 2026

Conditions

Kidney Transplant

Keywords

kidney transplantdd-cfDNAcell-free DNAallograft rejectiondonor derived cell-free DNAkidney rejectionrejection

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    7 years

Secondary Outcomes (4)

  • Association of dd-cfDNA levels

    7 years

  • Graft survival

    7 years

  • Biopsy rate and yield

    7 years

  • Time-to-intervention impact

    7 years

Study Arms (1)

Kidney transplant recipients

Adult kidney transplant recipients at least 2 weeks post-kidney transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult kidney transplant recipients across up to 60 student centers in the United States.

You may qualify if:

  • 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.
  • years of age or older
  • Has a minimum of three clinical evaluations per year post-transplant.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • Benning, L, Akifova, A, Oellerich, M, et al. Better together: improving diagnostic performance of kidney allograft rejection with a model combining relative fraction and absolute copies of donor-derived cell-free DNA - results from five independent cohorts. (submitted).

    BACKGROUND

  • Huang Y, Farkash E (2016). Protocol biopsies: utility and limitations. Advances in Chronic Kidney Disease, 23(5): 326-331.

    BACKGROUND

  • Khush K, Hall S, Kao A, et al (2024). Surveillance with dual noninvasive testing for acute cellular rejection after heart transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry. J Heart Lung Transplant 43(9):1409-1421.

    BACKGROUND

  • Halloran P, Reeve J, Madill-Thomsen K, et al. (2022). Combining Donor-derived Cell-free DNA Fraction and Quantity to Detect Kidney Transplant Rejection Using Molecular Diagnoses and Histology as Confirmation. Transplantation 106: 2435-2442.

    BACKGROUND

  • Akifova A, Budde K, Choi M, et al. (2023). Donor-Derived Cell-Free DNA in Biopsy-Proven Antibody-Mediated Rejection Versus Recurrent IgA Nephropathy After Kidney Transplantation. Kidney International Reports doi:10.1016/j.ekir.2023.07.011.

    BACKGROUND

  • Oellerich M, Shipkova M, Asendorf T, et al. (2019) 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: 19(11):3087.

    BACKGROUND

  • Beck J, Bierau S, Balzer S, et al. (2013). 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 59(12):1732.

    BACKGROUND

  • Bu L, Gupta G, Pai A, et al. (2022). Clinical outcomes from the Assessing Donor-derived cell- free DNA Monitoring Insights of kidney Allografts with Longitudinal surveillance (ADMIRAL) study. Kidney Int 101(4):793-803.

    BACKGROUND

  • Hysi 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Farouk S, Rein J (2020). The Many Faces of Calcineurin Inhibitor Toxicity - What the FK? Adv Chronic Kidney Dis 27(1): 56-66.

    BACKGROUND

  • Osmanodja B, Akifova A, Oellerich M, et al (2023). Donor-Derived Cell-Free DNA for Kidney Allograft Surveillance after Conversion to Belatacept: Prospective Pilot Study. J Clin Med 12(6): 2437.

    BACKGROUND

  • Osmanodja B, Akifova A, Budde K, et al. (2024). Donor-Derived Cell-Free DNA as a Companion Biomarker for AMR Treatment with Daratumumab: Case Series. Transpl Int 37:13213.

    BACKGROUND

  • Mayer KA, Schrezenmeier E, Diebold M, et al. A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection (2024) NEJM DOI: 10.1056/NEJMoa2400763.

    BACKGROUND

  • Akifova A, Budde K, Amann K, et al. 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.

    BACKGROUND

  • Aubert O, Ursule-Dufait C, Brousse R, et al. (2024). Cell-free DNA for the detection of kidney allograft rejection. Nature Medicine, 30(8):2320-2327.

    BACKGROUND

  • Bromberg JS, Bunnapradist S, Samaniego-Picota M, et al. (2024). Elevation of Donor-derived Cell-free DNA Before Biopsy-proven Rejection in Kidney Transplant. Transplantation 108(9):1994-2004.

    BACKGROUND

  • Osmanodja B, Akifova A, Oellerich M, et al. (2023). Longitudinal dd-cfDNA Monitoring Reduces TIME to ABMR Diagnosis in dnDSA Positive Kidney Transplant Recipients: A Diagnostic Randomized Clinical Trial. Amsterdam, Netherlands: ESOT Congress Abstract Book, Late Breaking Full Orals (2023).

    BACKGROUND

  • Akifova A, Budde K, Oellerich M, et al. (2024). Perspective for Donor-Derived Cell-Free DNA in Antibody-Mediated Rejection After Kidney Transplantation: Defining Context of Use and Clinical Implications. Transpl Int 37:13239.

    BACKGROUND

  • Oellerich M, Sherwood K, Keown P, et al. (2021). Liquid biopsies: donor-derived cell-free DNA for the detection of kidney allograft injury. Nat Rev Nephrol 17(9):591-60.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Central Study Contacts

Annum Zhara, MSc.

CONTACT

1-949-554-4946azhara@imdxinc.com

Nick Ioannou, MD, PHD, MHA

CONTACT

630-596-3332nioannou@imdxinc.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 27, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

June 1, 2033

Last Updated

May 1, 2026

Record last verified: 2026-04