# STTR Phase II: Advance Early Detection of Lupus Nephritis with ClearGold

> **NIH NIH R42** · CLEARNANO, INC. · 2022 · $605,187

## Abstract

Abstract
 Systemic lupus erythematosus (SLE) or lupus is an autoimmune disease that affects more than 5 million
people worldwide, including 1.5 million Americans. Nearly 60% of these patients will develop lupus nephritis,
which can cause kidney failure. Thus, its financial burden to individual patient can reach $70,000/year, much
higher than many other diseases because of kidney transplantation. Although early treatment of lupus nephritis
can significantly slow down or even prevent the disease progression to kidney failure, proteinuria, our current
clinical standard for screening lupus patients, is not sensitive and accurate enough for early detection of lupus
nephritis. While new endogenous biomarkers or exogenous markers are being tested in clinical trials for early
diagnosis of lupus nephritis, none of them has outperformed proteinuria in the clinics. As a result, even today,
proteinuria remains the clinical standard and there are strong unmet needs for early detection and accurate
monitoring of kidney damages in the lupus patients. To address this unmet need, ClearNano Inc. is developing
a test agent, named “ClearGold” that can be used as an exogenous urine marker to detect lupus nephritis much
earlier and more accurately than proteinuria. Sponsored by previous STTR Phase I grant, using a renal clearable
gold nanoparticle as a prototype test agent, ClearNano has successfully validated the feasibility of ClearGold in
detection and staging of lupus nephritis in mouse model much earlier and more accurately than proteinuria, and
found it also outperformed other classical endogenous and exogenous markers being evaluated in the clinical
trials for lupus nephritis detection. In this STTR Phase II application, we will identify a lead product, develop
large-scale synthesis under Good Laboratory Practice (GLP) guidelines and conduct in-house toxicity study in
rat model. The success will allow us to prepare a strong package for pre-Investigational New Drug (IND)
meeting with FDA, reduce the risk for comprehensive toxicology studies carried by CRO, and accelerate the
clinical translation of this novel nanotechnology; so that a long-standing unmet need in the early detection of
lupus nephritis can be eventually addressed with our “ClearGold” test agent, which represents a $1.6 Billion
market opportunity.

## Key facts

- **NIH application ID:** 10494086
- **Project number:** 5R42DK123943-03
- **Recipient organization:** CLEARNANO, INC.
- **Principal Investigator:** Mengxiao Yu
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $605,187
- **Award type:** 5
- **Project period:** 2019-09-19 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10494086

## Citation

> US National Institutes of Health, RePORTER application 10494086, STTR Phase II: Advance Early Detection of Lupus Nephritis with ClearGold (5R42DK123943-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10494086. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*