# Noninvasive Biomarker Detection of Early Kidney Disease in Patients with Insulin Resistance

> **NIH NIH R43** · AMDX PROGNOSTX INCORPORATED · 2021 · $263,715

## Abstract

PROJECT SUMMARY
There are over 420 million people living with type 2 diabetes mellitus (T2DM) in the world today and about 165
million also have chronic kidney disease (CKD). The prevalence of CKD is up to 5-fold higher in those with
T2DM – in fact, >50% of all T2DM patients will develop CKD in their lifetime. The presence of comorbid CKD in
diabetes shortens average life expectancy by ~16-years, and results in ~$250 billion/yr in healthcare costs.
Annual mortality rates, manifestation of life-impairing comorbidities like cardiovascular disease, and overall
healthcare spending are all greatly increased as CKD severity progresses in T2DM. There is a significant
unmet clinical need to identify CKD early in the course of diabetes. Impact of early diagnosis (and proactive
implementation of CKD management) in the beginning stages of insulin resistance has been recognized by
multiple international societies, yet, no early diagnostic test exists. Prediabetes, the precursor condition to
T2DM, currently affects an estimated 88 million U.S. adults, and nearly 90% are unaware of their condition,
suggesting that many of these patients are uninhibitedly progressing. While therapeutic intervention is known,
proactive medical treatment for every prediabetic patient is impractical since most are low-risk for acutely
developing T2DM or kidney disease. Recent findings suggest that a hitherto unclassified pathophysiological
process results in rapid progression of prediabetes to T2DM, as well as early development of late-stage CKD.
Yet, there is currently no mechanism in place to predict or stratify this “high-risk” subpopulation within
prediabetes (that would benefit from early implementation of targeted medical therapy). AMDX PROGNOSTX will
produce a new ELISA test that indicates the presence of an ongoing, subclinical pathological process
that accelerates T2DM-associated comorbidities and rapid development of irreversible CKD in those
with insulin resistance as early as the prediabetic stage. Our test is based on the use of a novel biomarker
that reflects critical events in the pathophysiology of CKD progression within this specific prediabetic/early
T2DM population. Preliminary results demonstrate that patients with elevated levels of this biomarker either
already have, or rapidly develop CKD, and have a particularly high mortality rate. In this Phase I proposal, we
will further develop and test our prototype mAb-based assay on longitudinal human samples to evaluate its
ability to discern between two populations: i) prediabetic patients who readily developed CKD and T2DM after
the onset of their diagnosis, and ii) prediabetic patients who never develop any form of CKD and/or T2DM.
Results of this test will offer physicians a new dimension of insight that will redefine the field of diabetes and
CKD management and offer advancements in the clinical decision-making process by prompting early medical
treatment that will slow, and possibly prevent, progression to lat...

## Key facts

- **NIH application ID:** 10323624
- **Project number:** 1R43DK129132-01A1
- **Recipient organization:** AMDX PROGNOSTX INCORPORATED
- **Principal Investigator:** AARON L CARRITHERS
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $263,715
- **Award type:** 1
- **Project period:** 2021-08-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10323624

## Citation

> US National Institutes of Health, RePORTER application 10323624, Noninvasive Biomarker Detection of Early Kidney Disease in Patients with Insulin Resistance (1R43DK129132-01A1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10323624. Licensed CC0.

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