HistoMap AlloSure Renal Biopsies Observational Research Study
NCT07927374, Not yet recruiting, CareDx
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | HistoMap AlloSure Renal Biopsies Observational Research Study | ClinicalTrials.gov |
| NCT number | NCT07927374 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 1,250 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | CareDx | ClinicalTrials.gov |
| Conditions | Kidney Transplant Rejection, T-Cell Mediated Rejection, Kidney Transplantation, Antibody Mediated Rejection | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Unique Participants Providing Repository Specimens | 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. | ClinicalTrials.gov |
| Primary | Frequency and Proportion of Specimens Collected Without Nonconformities | 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. | ClinicalTrials.gov |
| Primary | Frequency and Proportion of Biopsies With Associated HistoMap, AlloSure, and Additional Streck Tube Collection | 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. | ClinicalTrials.gov |
| Primary | Frequency and Proportion of Participants With Each Kidney Rejection Type | 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. | ClinicalTrials.gov |
| Secondary | Clinical Performance Characteristics of HistoMap Relative to Histopathology | Index biopsy assessment. | Clinical performance characteristics of HistoMap for classification of kidney allograft rejection relative to histopathology in a real world setting. | ClinicalTrials.gov |
| Secondary | Concordance of Rejection Status Across HistoMap, AlloSure, and Histopathology | Index biopsy assessment. | Concordance rate of rejection status among HistoMap, AlloSure, and histopathology assessments. | ClinicalTrials.gov |
| Secondary | Association Between HistoMap Classification and Kidney Function | 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). | ClinicalTrials.gov |
| Secondary | Association Between HistoMap Results and Predicted Graft Survival | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)