# VisR Ultrasound for Monitoring Antibody-Mediated Rejection in Renal Transplant Patients

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $656,400

## Abstract

PROJECT SUMMARY
For the 786,000 people in the United States living with end stage renal disease (ESRD), the treatment of
choice is kidney transplantation. While transplant life has subtly increased over the last 15 years, ten-year graft
survival rates are only 28% for deceased-donor and 46% for living-donor grafts. The primary cause of graft
failure after the first year is antibody-mediated rejection (AMR), the detrimental impacts of which are
compounded by concurrent fibrosis. Thus, there is an urgent yet unmet need to prolong graft life by
remediating AMR prior to extensive fibrotic changes and other severe, irreversible graft damage. Therapeutic
interventions to remediate AMR are not FDA approved or clinically standardized due to their inconsistent and
often suboptimal performances. Promising treatment protocols are in development, but their translation to
clinical trials will require frequent monitoring of AMR response that cannot be supported by the current
evaluation standard, invasive biopsy, due to its associated safety risks. A safer alternative involves tracking
surrogate serum and urine biomarkers, but these markers are nonspecific with unclear diagnostic thresholds,
and measurable fluctuations in their values may occur well after underlying pathological changes to the
allograft. Another safe alternative to biopsy is imaging, most often ultrasound, which also indicates AMR
nonspecifically. The lack of a noninvasive and specific method for detecting AMR and routinely monitoring its
response to treatment in renal transplant patients represents a major gap in prolonging graft life. To fill this
gap, our group has spent the first five-year cycle of this grant award developing noninvasive Viscoelastic
Response (VisR) ultrasound for monitoring renal transplant status. Our research has demonstrated that in vivo
VisR assessments of elastic and viscous differences across the medulla and cortex, as well as medullary and
cortical elastic and viscous anisotropy, delineate renal inflammation and fibrosis in a pig model. Further, in a
pilot clinical feasibility study, our research has shown that in vivo VisR differentiates biopsy-confirmed
tubulointerstitial fibrosis in the allografts of human patients imaged serially from time of implantation. The
success of our investigations thus far motivates further advancement of VisR technology and its extension to
noninvasively detecting and monitoring AMR. Specifically, we will augment the VisR methods developed in the
first funding cycle with a new approach to anisotropy measurement (angle interpolation) and a new imaging
method (Double Profile Intersection (DoPIo) ultrasound) to improve the sensitivity and specificity of detecting
inflammation, a hallmark of AMR. We will apply the advanced VisR and DoPIo methods to identifying AMR and
monitoring its response to treatment in human renal transplant patients. We hypothesize that advanced VisR
and DoPIo ultrasound delineate biopsy-confirmed inflammation assoc...

## Key facts

- **NIH application ID:** 10775770
- **Project number:** 5R01DK107740-06
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Caterina M Gallippi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $656,400
- **Award type:** 5
- **Project period:** 2016-03-01 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10775770

## Citation

> US National Institutes of Health, RePORTER application 10775770, VisR Ultrasound for Monitoring Antibody-Mediated Rejection in Renal Transplant Patients (5R01DK107740-06). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10775770. Licensed CC0.

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