# VIRTUUS Children's Study: Validating Injury to the Renal Transplant Using Urinary Signatures in Children

> **NIH NIH R01** · CHILDREN'S HOSP OF PHILADELPHIA · 2020 · $641,442

## Abstract

PROJECT SUMMARY
 The overarching objectives of this proposal are to investigate whether existing urinary mRNA and
metabolite profiles, which are diagnostic and prognostic for early renal allograft injury in adults, can be
validated in pediatric kidney transplant recipients.
 Children with end-stage renal disease (ESRD) have a life expectancy at least 20 years shorter than
children without renal disease. During their lifetime, most children with ESRD will require several kidney
transplants to prolong duration and quality of life. Each transplant incurs new surgical and immunological risk.
Despite substantial gains in improving short-term allograft outcomes through improved immunosuppressive
regimens, the half-life of a kidney transplant is still only 10-12 years. Thus, there is a critical need to prolong
allograft survival. A major hindrance to advancing long-term outcomes is the inability to reliably detect early
allograft injury before clinical manifestations arise. Early allograft injury results from acute cellular or antibody-
mediated rejection or early emergence of viruses, primarily BK virus which leads to BK virus nephropathy.
 This project’s specific aims are: 1) to validate highly sensitive and specific adult urinary cell mRNA
signatures to diagnose and predict acute cellular rejection (ACR) in pediatric recipients, 2) to evaluate the
clinical efficacy of urine metabolite profiling to diagnose and prognosticate ACR in pediatric recipients and to
validate the sensitivity and specificity of a combined adult kidney allograft urinary mRNA and metabolite
signature for ACR in pediatric recipients and 3) to investigate if BKV-VP-1 mRNA levels in urinary cells are
diagnostic of BK virus associated nephropathy, and if urinary cell levels of Plasminogen Activator Inhibitor-1
mRNA and serum creatinine, predict future graft failure. These aims will be achieved through the collaborative
effort of key pediatric kidney transplant programs across the United States and Canada, supported by two
outstanding labs at Weill Cornell Medicine and Stanford. This study’s results will advance the ability to identify
and characterize early allograft injury in pediatric kidney allograft recipients through non-invasive immune
surveillance. By doing so, we will create opportunities to better inform clinical decision-making, improving
practice paradigms to promote positive long-term graft outcomes.

## Key facts

- **NIH application ID:** 9934218
- **Project number:** 5R01HD091185-04
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** Sandra Amaral
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $641,442
- **Award type:** 5
- **Project period:** 2017-08-10 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9934218

## Citation

> US National Institutes of Health, RePORTER application 9934218, VIRTUUS Children's Study: Validating Injury to the Renal Transplant Using Urinary Signatures in Children (5R01HD091185-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9934218. Licensed CC0.

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