HistoMap AlloSure Renal Biopsies Observational Research Study
Kidney Transplant Rejection · T-Cell Mediated Rejection · Kidney Transplantation · Antibody Mediated Rejection
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 1250 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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.
Study population
Adult kidney transplant recipients with a functioning kidney allograft undergoing a clinically indicated kidney allograft biopsy at participating U.S. transplant centers.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Number of Unique Participants Providing Repository Specimens
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Secondary measures
Clinical Performance Characteristics of HistoMap Relative to Histopathology
Time frame: 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
Time frame: Index biopsy assessment.
Concordance rate of rejection status among HistoMap, AlloSure, and histopathology assessments.
Association Between HistoMap Classification and Kidney Function
Time frame: 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
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- CareDx
- Study start
- 2026-12 Estimated
- Primary completion
- 2028-12 Estimated
- Study completion
- 2029-12 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
HistoMap AlloSure Renal Biopsies Observational Research Study
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026