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NCT06438107 · ClinicalTrials.gov registry record
Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes
A clinical trial, sponsored by University of Pittsburgh.
- Not yet
- Registry status
- 24
- Enrollment target
NCT06438107: Clinical Trial study, sponsored by University of Pittsburgh.
NCT06438107 is a clinical trial that has not yet begun recruiting, run by University of Pittsburgh. The registered enrollment target is 24 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06438107 has not yet begun recruiting, sponsored by University of Pittsburgh.
- NOT YET RECRUITING
- Registry status
- 24 participants
- Enrollment target
Study Summary
The goal of this observational study is to determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection in renal transplant rejection. The main questions it aims to answer are: * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in acute ejection. * To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and compare the transcriptional and epigenetic changes within these cells in recurrent/recalcitrant rejection vs. rejection that resolves with therapy. * To determine phenotypic changes associated with chronic rejection. Participants will be asked to provide the following research specimens: * Renal biopsy specimens at the following timepoints: day of transplantation (pre-implantation and post-perfusion); routine protocol biopsies at 3 months and 12 months; and clinically indicated for-cause biopsies at any timepoint from time-0 to 1-yr post-transplantation. The 1st research core will be used for routine histopathological examination and left over tissue from this core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The second research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq. * Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). For each collection timepoint, up to 75 mL (about 5 tablespoons) will be collected. * Prospective clinical data and outcomes will be collected from participant medical records. * Follow-Up Period: For-cause biopsies from 1-
Primary Outcome
Percentage biopsy proven acute rejection either on a surveillance biopsy or a for-cause biopsy in the First Post-Transplant Year
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2026-04 |
| Est. Completion | 2030-07 |
What is known before NCT06438107 opens enrollment
NCT06438107 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT06438107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06438107 about?
NCT06438107 is a clinical study titled "Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes". The goal of this observational study is to determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection in renal transplant rejection. The main questions it aims to answer are: * To determine the phenotype, frequency, location, and the inter-cellular interactions...
What is the current status of trial NCT06438107?
This trial is currently not yet recruiting. The enrollment target is 24 participants. The study started on 2026-04. Estimated completion is 2030-07.
Who is sponsoring clinical trial NCT06438107?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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