# AKI-Sapere- a novel prognostic of Acute Kidney Injury due to cardiac surgery

> **NIH NIH R44** · SAPERE BIO, INC. · 2020 · $893,202

## Abstract

ABSTRACT
Acute kidney injury (AKI) is common, expensive to treat, and associated with >50% mortality. Each year, millions
of patients undergo cardiovascular surgery, medical imaging, or cytotoxic chemotherapy, all of which place them
at significant risk for AKI. Around 30% of cardiac surgery patients develop AKI, with even mild AKI significantly
increasing the risk of negative outcomes such as progression to chronic kidney disease and 30-day mortality.
Although recent research on renal biomarkers has shown promise in diagnosing AKI progression, as yet no
tests or models can effectively identify prior to surgery patients at risk for AKI initiation. If patients at risk for
developing AKI can be accurately identified before surgery, preoperative and perioperative procedures could be
modified to minimize the risk of AKI. Such risk minimization is particularly important since there are no
pharmacologic therapies available for the effective prevention or treatment of AKI.
Therefore, a clinical tool to predict AKI prior to its initiation remains a critical unmet need. Only through early
prediction can clinicians make informed decisions to improve the care of patients at risk of AKI and to limit the
burden of this catastrophic complication of surgery and critical illness. By utilizing our novel and robust assay for
measuring a patient’s “molecular age”, HealthSpan Dx has developed AKI-Sapere, a multivariate assay that
can successfully identify patients at risk for AKI initiation prior to coronary artery bypass graft (CABG)
surgery. AKI-Sapere combines measurement of our innovative marker of molecular age along with a DNA
marker of genetic predisposition for cardiovascular disease, and a baseline measurement of renal function. In a
pilot study of 96 patients undergoing CABG procedures, AKI-Sapere predicted risk of AKI and was
superior to AKI risk models composed of clinical variables, such as the Cleveland Clinic Thakar score,
or a panel of ten renal biomarkers known to predict AKI progression.
In this Fast Track proposal, we propose to conduct multi-center clinical trials to refine the risk score and validate
the clinical utility of AKI-Sapere to identify patients at risk for AKI prior to CABG. Completion of these aims will
demonstrate the clinical utility of AKI-Sapere in CABG patients and will allow us to bring this test to market, first
as a lab developed test (LDT) and ultimately as an FDA-approved device. Prediction of AKI initiation by AKI-
Sapere has the potential to dramatically change clinical practice by providing a significantly greater opportunity
to intervene, to alter the ensuing renal insult, to council patients and clinicians, and to ultimately diminish the
impact of AKI and the associated morbidity on patients and healthcare. Furthermore, use of AKI-Sapere for
patient stratification in multiple settings would catalyze the clinical development of novel preventative and
treatment strategies for AKI, including potentially AKI caused by sour...

## Key facts

- **NIH application ID:** 10001147
- **Project number:** 4R44AG060888-02
- **Recipient organization:** SAPERE BIO, INC.
- **Principal Investigator:** Natalia Mitin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $893,202
- **Award type:** 4N
- **Project period:** 2018-09-30 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10001147

## Citation

> US National Institutes of Health, RePORTER application 10001147, AKI-Sapere- a novel prognostic of Acute Kidney Injury due to cardiac surgery (4R44AG060888-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10001147. Licensed CC0.

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