HistoMap AlloSure Renal Biopsies Observational Research Study
Kidney Transplant Rejection · T-Cell Mediated Rejection · Kidney Transplantation · Antibody Mediated Rejection
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 1250 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The HistoMap AlloSure Renal Biopsies Observational Research Study (HARBOR) is a prospective, multicenter, observational cohort study of adult kidney transplant recipients undergoing a clinically indicated kidney allograft biopsy. The study will collect biospecimens and associated clinical data to support the development and evaluation of molecular approaches for assessing kidney allograft rejection. It will also examine relationships among histopathology, tissue-based gene expression profiling using HistoMap, donor-derived cell-free DNA (dd-cfDNA) measured using AlloSure, and clinical outcomes. As an observational study, HARBOR will not direct clinical care, and all diagnostic and treatment decisions will remain at the discretion of the treating clinicians in accordance with standard clinical practice.
Leer la descripción completa
HARBOR will include enrollment of approximately 1,250 adult kidney transplant recipients undergoing clinically indicated kidney allograft biopsies at U.S. transplant centers. The study will prospectively collect blood and tissue specimens, biopsy findings, molecular test results, and associated clinical data to support research on kidney allograft rejection.
Histopathologic findings will be assessed in relation to results from HistoMap, a tissue-based gene expression profiling assay, and AlloSure, a donor-derived cell-free DNA assay. Secondary analyses will evaluate agreement among diagnostic assessments and associations with kidney allograft function and outcomes.
Participants will be classified into two observational cohorts using index-biopsy findings and AlloSure results. All participants will undergo an assessment at Month 1. Participants meeting criteria for Cohort 1 will have additional assessments at Months 3 and 6, with a final assessment at Month 12; participants in Cohort 2 will complete study follow-up at Month 1. The study will not assign or direct treatment, and all clinical management decisions will remain at the discretion of the treating clinicians according to standard of care.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Adult age 18 or older at time of informed consent
- Kidney transplant recipient with a functioning allograft
- Undergoing an indicated biopsy per transplant center's SOC, based on any traditional metrics of function (eGFR, Serum Creatinine, proteinuria) or donor-specific antibodies (DSA) or dd-cfDNA
- Enrolled within 14 days prior to biopsy.
- Willing and able to provide informed consent to participate in the study.
- Willing and able to comply with study visits and procedures, including scheduled sample collections and clinical assessments.
Exclusion Criteria:
- Has received a multi-organ transplant (e.g., liver-kidney, heart-kidney)
- Pregnant at the time of enrollment.
- Receiving kidney from patient's homozygous twin
- Deemed by researchers to be unsuitable for clinical study, due to known medical or psychological condition(s) that might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of study outcomes.
- Active systemic bacterial or fungal infection within 14 days prior to biopsy.
- Current malignancy or receiving treatment for malignancy except for non-melanoma skin cancer.
Población del estudio
Adult kidney transplant recipients with a functioning kidney allograft undergoing a clinically indicated kidney allograft biopsy at participating U.S. transplant centers.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Cohort 1
Kidney transplant recipients with rejection or related findings identified by histopathology or HistoMap, BK nephropathy on the index biopsy, or an AlloSure dd-cfDNA result ≥0.5%. Study follow-up includes assessments at Months 1, 3, and 6 after the index biopsy and an end-of-study assessment at Month 12.
Cohort 2
Kidney transplant recipients without evidence of rejection by histopathology or HistoMap, without BK nephropathy on the index biopsy, and with an AlloSure dd-cfDNA result \<0.5%. The Month 1 assessment serves as the end-of-study visit.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Number of Unique Participants Providing Repository Specimens
Plazo: Index biopsy through the last protocol-specified collection, up to Month 6 after index biopsy.
Number of unique participants contributing biospecimens, summarized by specimen type and study visit.
Frequency and Proportion of Specimens Collected Without Nonconformities
Plazo: Index biopsy through the last protocol-specified collection, up to Month 6 after index biopsy.
Frequency and proportion of specimens collected and processed according to the laboratory manual without collection or processing nonconformities.
Frequency and Proportion of Biopsies With Associated HistoMap, AlloSure, and Additional Streck Tube Collection
Plazo: Through study completion (up to 12 months following index biopsy).
Frequency and proportion of biopsies with associated tissue gene expression profiling (HistoMap), AlloSure testing, and at least one additional Streck blood tube collected.
Frequency and Proportion of Participants With Each Kidney Rejection Type
Plazo: Index biopsy assessment.
Frequency and proportion of participants classified into each kidney rejection category based on study assessments. Rejection categories will be reported separately for histopathology and HistoMap assessments.
Medidas secundarias
Clinical Performance Characteristics of HistoMap Relative to Histopathology
Plazo: Index biopsy assessment.
Clinical performance characteristics of HistoMap for classification of kidney allograft rejection relative to histopathology in a real world setting.
Concordance of Rejection Status Across HistoMap, AlloSure, and Histopathology
Plazo: Index biopsy assessment.
Concordance rate of rejection status among HistoMap, AlloSure, and histopathology assessments.
Association Between HistoMap Classification and Kidney Function
Plazo: Months 1, 3, and 6 post-index biopsy.
Association between index-biopsy HistoMap classification (AMR, TCMR, Mixed Rejection, or No Rejection) and kidney function as measured by estimated glomerular filtration rate (eGFR).
Association Between HistoMap Results and Predicted Graft Survival
Plazo: Predicted graft survival at 3, 5, and 7 years using assessments performed at Months 3 and 6 post-index biopsy.
Association of graft survival probabilities calculated using the iBox Prediction System across HistoMap results.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
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No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- CareDx
- Inicio del estudio
- 2026-12 Estimado
- Finalización primaria
- 2028-12 Estimado
- Finalización del estudio
- 2029-12 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
HistoMap AlloSure Renal Biopsies Observational Research Study
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026