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

> **NIH NIH UH3** · JOHNS HOPKINS UNIVERSITY · 2020 · $299,998

## Abstract

Abstract
Acute kidney injury (AKI) is a common condition and is associated with both short- and long-term adverse
outcomes in those who develop it. Translational research studies of actual human kidney tissue during an AKI
event can lead to discovery of novel AKI pathways and therapeutic targets.
In response to the RFA-DK-16-026, also known as the Kidney Precision Medicine Program, our proposal aims
to safely and ethically enroll a diverse group of participants with AKI. Our proposal aims to balance the need
for obtaining kidney tissue from a diverse AKI population with the risks of obtaining this tissue. Kidney biopsies
carry a small but significant risk of bleeding which may be somewhat increased in the setting of AKI.
In the AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue) Study, we propose that the
optimal way to obtain tissue in AKI patients would be through a combination of approaches. First, we will obtain
extra tissue at the time of clinically indicated kidney biopsies, since prior data suggests that this approach does
not add additional bleeding risk. We will carefully select participants who are at lower risk of bleeding. Over the
last two years, we have enrolled over 200 participants in a research study and collected kidney biopsies from
them. Over 70% of these participants said that they would be willing to donate extra tissue for research.
Second, to encompass the whole AKI spectrum from its mildest to severest forms, we will also biopsy kidneys
in deceased donors. The causes of AKI in deceased donors are similar to those experienced by critically ill AKI
patients. Obtaining biopsies in this setting is low-risk; we have successfully enrolled over 900 deceased
patients who received kidney biopsies in an ongoing NIH-funded project. Third, we will obtain research-only
biopsies in specially-selected settings of hepatorenal syndrome and obstructive kidney disease when bleeding
risk is low.
In the UG3 phase, our aim is to obtain biopsies from 90-100 participants over two years and closely monitor
patient safety. We will establish a community advisory board of AKI patients in addition to a data and safety
monitoring board for the study. We will share data within the consortium after removal of patient identifiers. We
will also establish linkages with various electronic medical record system as well as administrative databases
to streamline follow-up. In the UH3 phase, we will expand our study to other sites and settings based on the
biopsy quality and safety data from UG3 phase and enroll 375 participants over three years. We will also
conduct longitudinal follow-up on all participants using various mechanisms which were effective for us in the
past.

## Key facts

- **NIH application ID:** 10003239
- **Project number:** 5UH3DK114866-04
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Chirag R Parikh
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $299,998
- **Award type:** 5
- **Project period:** 2018-07-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10003239

## Citation

> US National Institutes of Health, RePORTER application 10003239, AKI Matched Phenotype Linked Evaluation with Tissue (AMPLE-Tissue) (5UH3DK114866-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10003239. Licensed CC0.

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