# AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue)

> **NIH NIH U01** · JOHNS HOPKINS UNIVERSITY · 2024 · $549,999

## Abstract

Abstract
Although acute kidney injury (AKI) is common and associated with adverse consequences, no specific AKI
therapy has emerged. This has been attributed to the heterogeneity of human AKI, which is poorly modeled by
animal experiments. The Kidney Precision Medicine Program (KPMP) was established by the NIH/NIDDK in
2016 to study human kidney tissue during an AKI event in order to discover pathogenic pathways and novel
therapeutic targets. The combined Johns Hopkins University (JHU)/Yale University site was funded in the first
phase of the KPMP to recruit AKI participants. During this first phase, the JHU/Yale site enrolled over one-half
of all AKI participants in KPMP, performed kidney biopsies with a strong commitment to safety and ethics,
retained all participants, and played an important role in the initiation and execution of study protocols through
committee leadership and participation. Enrollment was successfully restarted after a several-months-long
pause in recruitment due to the COVID-19 pandemic, and protocols were established to monitor participant
and staff safety. This is an application to continue to serve as an AKI recruitment site for the Kidney Precision
Medicine Program (KPMP) to create a high-quality, well-represented resource of tissues and biosamples from
hospitalized participants with AKI. The JHU/Yale center’s experience from the first phase of the study will be
invaluable as the consortium attempts to increase enrollment in the second phase. The specific aims are: 1) To
recruit a total of 150 diverse participants with AKI due to various etiologies and of varying severities in a
research study that safely and ethically performs protocol research biopsies to collect kidney tissue and obtain
concurrent biosamples and clinical data; 2) to retain participants in a longitudinal study using a hybrid approach
of active and passive follow-up that prioritizes participant convenience and obtains high-fidelity follow-up
information; and 3) to contribute biosamples from participants with various biopsy-proven etiologies of AKI from
larger cohorts with broader enrollment criteria to externally validate KPMP findings. In Aim 1, 30 diverse
participants with AKI per year will be enrolled across two academic medical centers while maintaining. high
safety and quality standards. In Aim 2, close to 100% follow-up of study participants will be obtained through
various approaches to garner information on objective measures of kidney health and patient-reported
outcomes. In Aim 3, to provide external validation of the KPMP findings, blood, urine, and DNA from over 500
participants who underwent routine clinically-indicated kidney biopsies for AKI will be contributed to the study.
Successful completion of these aims will result in the contribution of kidney tissue, biosamples, and data from
participants with AKI to the KPMP consortium to help achieve the broader goal of understanding the
pathogenesis of human AKI. This will lead to the identi...

## Key facts

- **NIH application ID:** 10893372
- **Project number:** 5U01DK114866-08
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Chirag R Parikh
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $549,999
- **Award type:** 5
- **Project period:** 2017-09-12 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10893372

## Citation

> US National Institutes of Health, RePORTER application 10893372, AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue) (5U01DK114866-08). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10893372. Licensed CC0.

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