GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

Официальное название

GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Detect Rejection [Срок оценки: 7 years]
• Validate Superiority of Combination Model-score (CM-score) [Срок оценки: 7 years]

Вторичные конечные точки (4)

• Association of dd-cfDNA levels [Срок оценки: 7 years]
• Graft survival [Срок оценки: 7 years]
• Biopsy rate and yield [Срок оценки: 7 years]
• Time-to-intervention impact [Срок оценки: 7 years]

Критерии участия

Inclusion Criteria: Prospective Participant

• 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.

Inclusion Criteria: Historical Control Participant

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

Exclusion Criteria: Prospective Participant

• 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.

Exclusion Criteria: Historical Control Participant

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Cooperman Barnabas Medical Center — Livingston

Публикации

• 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 1 PMID 42269874
• Huang 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. PMID 27742388
• Khush 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 PMID 38759766
• Halloran 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. Transplan PMID 35765145
• Akifova 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. PMID 37849995
• Oellerich 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 PMID 31062511
• Beck 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. PMID 24061615
• Bu 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. PMID 34953773

Идентификаторы

NCT: NCT07551531 · GAL-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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