Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-01 @ 3:32 AM
Study NCT ID:
NCT04239703
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2020-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trifecta-Kidney cfDNA-MMDx Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'RNA isolated from kidney biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2020-01-14', 'studyFirstSubmitQcDate': '2020-01-23', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calibration of Prospera test for T cell-mediated rejection', 'timeFrame': '18 months', 'description': 'Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.'}, {'measure': 'Calibration of Prospera test for antibody-mediated rejection', 'timeFrame': '18 months', 'description': 'Calibration of DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.'}, {'measure': 'Calibration of Prospera test for kidney injury', 'timeFrame': '18 months', 'description': 'Calibration of DD-cfDNA test cut-off values against the probability of acute and chronic kidney injury in the biopsy as reported by MMDx.'}, {'measure': 'Report calibrated Prospera test results for rejection', 'timeFrame': '6 months', 'description': 'Report new DD-cfDNA test cut-off values for rejection'}, {'measure': 'Report calibrated Prospera test results for kidney injury', 'timeFrame': '6 month', 'description': 'Report new DD-cfDNA test cut-off values for acute and chronic kidney injury'}], 'secondaryOutcomes': [{'measure': 'Determine if Prospera blood test can replace kidney biopsy test', 'timeFrame': '6 months', 'description': 'Determine if Prospera test, as calibrated by this DD-cfDNA-HLA-MMDx study, will avoid need for indication biopsy when kidney transplant function deteriorates. This will be based on the consensus between participating clinicians.'}, {'measure': 'Assessment of donor-specific antibody status', 'timeFrame': '6 months', 'description': 'Report and compare the DSA status based on centralized and local HLA antibody measurement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['donor derived cell-free DNA', 'blood', 'kidney biopsy'], 'conditions': ['Kidney Transplant Rejection']}, 'referencesModule': {'references': [{'pmid': '38819301', 'type': 'BACKGROUND', 'citation': 'Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.'}, {'pmid': '39883025', 'type': 'BACKGROUND', 'citation': 'Halloran PF, Madill-Thomsen KS. Donor-derived Cell-free DNA: A Step Forward in the Quest for Transplant Truth. Transplantation. 2025 Jun 1;109(6):910-914. doi: 10.1097/TP.0000000000005332. Epub 2025 Jan 28. No abstract available.'}, {'pmid': '35058354', 'type': 'RESULT', 'citation': 'Halloran PF, Reeve J, Madill-Thomsen KS, Demko Z, Prewett A, Billings P; Trifecta Investigators. The Trifecta Study: Comparing Plasma Levels of Donor-derived Cell-Free DNA with the Molecular Phenotype of Kidney Transplant Biopsies. J Am Soc Nephrol. 2022 Feb;33(2):387-400. doi: 10.1681/ASN.2021091191. Epub 2022 Jan 20.'}, {'pmid': '36190186', 'type': 'RESULT', 'citation': 'Halloran PF, Reeve J, Madill-Thomsen KS, Demko Z, Prewett A, Gauthier P, Billings P, Lawrence C, Lowe D, Hidalgo LG; the Trifecta Investigators. Antibody-mediated Rejection Without Detectable Donor-specific Antibody Releases Donor-derived Cell-free DNA: Results From the Trifecta Study. Transplantation. 2023 Mar 1;107(3):709-719. doi: 10.1097/TP.0000000000004324. Epub 2023 Feb 21.'}, {'pmid': '37310258', 'type': 'RESULT', 'citation': 'Halloran PF, Madill-Thomsen KS, Reeve J. The Molecular Phenotype of Kidney Transplants: Insights From the MMDx Project. Transplantation. 2024 Jan 1;108(1):45-71. doi: 10.1097/TP.0000000000004624. Epub 2023 Dec 13.'}, {'pmid': '35765145', 'type': 'RESULT', 'citation': '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. Transplantation. 2022 Dec 1;106(12):2435-2442. doi: 10.1097/TP.0000000000004212. Epub 2022 Nov 22.'}, {'pmid': '38150492', 'type': 'RESULT', 'citation': 'Gauthier PT, Madill-Thomsen KS, Demko Z, Prewett A, Gauthier P, Halloran PF; Trifecta-Kidney Investigators. Distinct Molecular Processes Mediate Donor-derived Cell-free DNA Release From Kidney Transplants in Different Disease States. Transplantation. 2024 Apr 1;108(4):898-910. doi: 10.1097/TP.0000000000004877. Epub 2023 Dec 27.'}, {'pmid': '40854490', 'type': 'RESULT', 'citation': 'Hidalgo LG, Madill-Thomsen KS, Reeve J, Mackova M, Gauthier P, Demko Z, Prewett A, Lee M, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Blosser CD, Bobba S, Brennan D, Bromberg J, Budde K, Chamienia A, Chow K, Ciszek M, Costa N, Deborska-Materkowska D, Debska-Slizien A, Domanski L, Fatica R, Francis I, Fryc J, Gill J, Gill J, Glyda M, Gourishankar S, Gryczman M, Gupta G, Hruba P, Hughes P, Jittirat A, Jurekovic Z, Kamal L, Kamel M, Kant S, Kojc N, Konopa J, Kumar D, Lan J, Lowe D, Mazurkiewicz J, Miglinas M, Moinuddin I, Mueller T, Myslak M, Naumnik B, Paczek L, Patel A, Perkowska-Ptasinska A, Piecha G, Poggio E, Bloudickova SR, Regele H, Schachtner T, Shojai S, Sikosana MLN, Slatinska J, Smykal-Jankowiak K, Haler ZV, Viklicky O, Vucur K, Weir MR, Wiecek A, Zaky Z, Halloran PF. Improving the histologic detection of donor-specific antibody-negative antibody-mediated rejection in kidney transplants. Am J Transplant. 2025 Aug 23:S1600-6135(25)02943-0. doi: 10.1016/j.ajt.2025.08.029. Online ahead of print.'}, {'pmid': '40980666', 'type': 'DERIVED', 'citation': 'Madill-Thomsen KS, Hidalgo LG, Demko ZP, Gauthier PM, Prewett A, Lowe D, Chang JJ, Mackova M, Budde K, Bromberg JS, Halloran PF; Trifecta-Kidney Study Group. Defining Relationships Among Tests for Kidney Transplant Antibody-Mediated Rejection. Kidney Int Rep. 2025 Jun 17;10(9):3225-3238. doi: 10.1016/j.ekir.2025.06.017. eCollection 2025 Sep.'}, {'pmid': '40232852', 'type': 'DERIVED', 'citation': 'Halloran PF, Chang J, Mackova M, Madill-Thomsen KS, Akalin E, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Blosser CD, Bohmig G, Brennan D, Bromberg J, Budde K, Chamienia A, Chow K, Ciszek M, de Freitas D, Deborska-Materkowska D, Debska-Slizien A, Djamali A, Domanski L, Durlik M, Einecke G, Eskandary F, Fatica R, Francis I, Fryc J, Gill J, Gill J, Glyda M, Gourishankar S, Gryczman M, Gupta G, Hruba P, Hughes P, Jittirat A, Jurekovic Z, Kamal L, Kamel M, Kant S, Kojc N, Konopa J, Lan J, Mannon RB, Matas A, Mazurkiewicz J, Miglinas M, Mueller T, Myslak M, Narins S, Naumnik B, Patel A, Perkowska-Ptasinska A, Picton M, Piecha G, Poggio E, Rajnochova Bloudickova S, Schachtner T, Shojai S, Sikosana ML, Slatinska J, Smykal-Jankowiak K, Solanki A, Veceric Haler Z, Viklicky O, Vucur K, Weir MR, Wiecek A, Wlodarczyk Z, Yang H, Zaky Z, Gauthier PT, Hinze C. A cross-sectional study of the role of epithelial cell injury in kidney transplant outcomes. JCI Insight. 2025 Apr 15;10(10):e188658. doi: 10.1172/jci.insight.188658. eCollection 2025 May 22.'}, {'pmid': '38538559', 'type': 'DERIVED', 'citation': 'Halloran PF, Reeve J, Mackova M, Madill-Thomsen KS, Demko Z, Olymbios M, Campbell P, Melenovsky V, Gong T, Hall S, Stehlik J. Comparing Plasma Donor-derived Cell-free DNA to Gene Expression in Endomyocardial Biopsies in the Trifecta-Heart Study. Transplantation. 2024 Sep 1;108(9):1931-1942. doi: 10.1097/TP.0000000000004986. Epub 2024 Aug 20.'}, {'pmid': '36508644', 'type': 'DERIVED', 'citation': 'Halloran PF, Madill-Thomsen KS. The Molecular Microscope Diagnostic System: Assessment of Rejection and Injury in Heart Transplant Biopsies. Transplantation. 2023 Jan 1;107(1):27-44. doi: 10.1097/TP.0000000000004323. Epub 2022 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.', 'detailedDescription': 'There is a need for better screening of kidney transplant patients for rejection. Patients with kidney transplants are routinely tested (creatinine, urine protein, histology and donor specific antibody (DSA) as standard of care to detect rejection, but these tests are not adequate. Rejection is often missed by these tests (false negatives) and other processes such as acute kidney injury can produce false-positive results. Moreover, histology has a high interobserver disagreement diagnosing rejection, and cannot accurately assess acute injury. A definitive molecular assessment of rejection and injury in kidney biopsies has emerged - the Molecular Microscope® Diagnostic System (MMDx) - developed by the Alberta Transplant Applied Genomics Centre, University of Alberta. Now a new screening test is being introduced: the monitoring of donor-derived cell-free DNA (DD-cfDNA) released in the blood by the kidney during rejection. The Natera Inc DD-cfDNA Prospera® test is based on the massively multiplex PCR that targets 13,392 single nucleotide polymorphisms and targeted sequences are quantified by Next Generation Sequencing. The Prospera® test done on kidney transplant recipients detected "active rejection" and differentiated it from borderline rejection and no rejection. It is likely, however, that DD-cfDNA test may miss some T cell-mediated rejection (TCMR) cases and the distinction between early and fully developed antibody-mediated rejection (ABMR) was not tested. No study has actually examined the DD-cfDNA results in kidney transplants with acute or chronic kidney disease (AKI and CKD). DD-cfDNA measurements have only been correlated with histology, a flawed standard. DD-cf-DNA test must now be calibrated against MMDx that is based on global gene expression, the new standard for biopsy interpretation. The present study will calibrate centrally measured (Natera Inc) DD-cfDNA levels obtained at the time of an indication biopsy against the MMDx measurements of TCMR, and ABMR (early-stage, fully-developed, and late-stage), AK, and atrophy-fibrosis. We will compare blood DD-cfDNA measurements in 600 samples at the time of 300 indication biopsies to the MMDx results, as well as central assessment of HLA antibody (One Lambda) in 300 blood samples, interpreted centrally as DSA based on the tissue typing results. This study is an extension of the INTERCOMEX ClinicalTrials.gov Identifier: NCT01299168. We have collected 1203 kidney biopsies and 2422 corresponding blood samples. We extend this study to the total of 1400 biopsies and 2800 blood samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All kidney transplant recipients undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enroll in the study.\n\nExclusion Criteria:\n\n* Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.'}, 'identificationModule': {'nctId': 'NCT04239703', 'briefTitle': 'Trifecta-Kidney cfDNA-MMDx Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Trifecta-Kidney cfDNA-MMDx Study: Comparing the DD-cfDNA Test to MMDx Microarray Test, Central HLA Antibody Test, and Histology.', 'orgStudyIdInfo': {'id': 'ATAGC05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney transplant biopsies for cause', 'description': 'The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care.', 'interventionNames': ['Diagnostic Test: MMDx', 'Diagnostic Test: Prospera', 'Diagnostic Test: HLA antibody']}], 'interventions': [{'name': 'MMDx', 'type': 'DIAGNOSTIC_TEST', 'description': 'Portion of kidney transplant indication biopsy', 'armGroupLabels': ['Kidney transplant biopsies for cause']}, {'name': 'Prospera', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['transplant patient blood sample'], 'description': 'Transplant patient blood sample', 'armGroupLabels': ['Kidney transplant biopsies for cause']}, {'name': 'HLA antibody', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['transplant patient blood sample'], 'description': 'Transplant patient blood sample', 'armGroupLabels': ['Kidney transplant biopsies for cause']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalie Remsen', 'role': 'CONTACT', 'email': 'nremsen@tgh.org'}, {'name': 'Rajendra Baliga, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raissa Toure', 'role': 'CONTACT', 'email': 'RToure@som.umaryland.edu'}, {'name': 'Jonathan Bromberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matt Weir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darin B Ostrander, PhD', 'role': 'CONTACT', 'email': 'dostran1@jhmi.edu', 'phone': '410-614-6702'}, {'name': 'Daniel C Brennan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Johns Hopkins University, School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rajeev Sharma, MD', 'role': 'CONTACT', 'email': 'rasharma@med.wayne.edu'}, {'name': 'Rajeev Sharma, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mareena Zachariah, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Detroit Medical Center, Harper University Hospital of Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Iman Francis', 'role': 'CONTACT', 'email': 'Ifranci1@hfhs.org'}, {'name': 'Milagros Samaniego-Picota, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Iman Francis, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anita Patel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Malone', 'role': 'CONTACT', 'email': 'amalone@wustl.edu'}, {'name': 'Andrew Malone, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tarek Ahamad, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Barnes-Jewish Hospital, Washington University at St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44106-5048', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine R Carter', 'role': 'CONTACT', 'email': 'Katherine.carter@uhhospitals.org'}, {'name': 'Jittirat Arksarapuk, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Cleveland Medical Ctr.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debra Camino', 'role': 'CONTACT', 'email': 'caminod@ccf.org'}, {'name': 'Emillio Poggio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Richard Fatica, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ziad Zaky, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jake Krong', 'role': 'CONTACT', 'email': 'Jake.Krong@imail.org'}, {'name': 'Sanjiv Anand, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Intermountain Transplant Services', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gaurav Gupta, MD', 'role': 'CONTACT', 'email': 'ggupta@mcvh-vcu.edu'}, {'name': 'Gaurav Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Layla Camal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Virginia Commonwealth University Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chris Blosser, MD', 'role': 'CONTACT', 'email': 'CBlosser@nephrology.washington.edu'}, {'name': 'Chris Bosser, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Nephrology & UW Organ Transplant Center University of Washington', 'geoPoint': {'lat': 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