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A proprietary digital platform for precision patient identification and enrollment of clinical trials for rare kidney diseases

Award Number: R44DK138688
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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A proprietary digital platform for precision patient identification and enrollment of clinical trials for rare kidney diseases - Project Summary The goal of this Direct to Phase II program is to develop and test the efficacy of a Precision Medicine Clinical Trials Enrollment Platform for kidney diseases. Approximately half of randomized controlled trials do not meet their recruiting target. Enrolling trials targeting rare kidney diseases is particularly challenging with many conditions subject to stratification and sub-typing, largely based on histopathological analysis. Due to Arkana’s position as the largest nephropathology practice in the U.S., drug developers often approach the company to assist in identifying patients with clinical indications of interest. Focusing recruitment on esoteric nephropathology is a unique and innovative approach to clinical trials enrollment, which is likely to have significant value to sponsors. Arkana is therefore in a one-of-a-kind position to support pathology-directed enrollment, with 25+ world-class renal pathologists and access to a large patient population required to form statistically valid cohorts, even for rare conditions. Arkana has already developed Arkana Connect™, a mobile app allowing clinicians to track the processing of patient biopsies and retrieve pathology reports. During a Phase I-equivalent program, the company initiated the development of key infrastructure to support pathology reporting and clinician communication on the app. Over 1,300 clinicians use the app routinely, providing a straightforward pathway for market entry of the updated enrollment app capabilities. The company has also benchmarked enrollment efficiency for multiple rare kidney diseases based on prior clinical trial enrollment projects undertaken with manual methods; we expect to at least double enrollments through development of technology that improves patient selection and the communication of trial availability with clinicians. Based on the success of Arkana Connect™, the company is eager to move forward with development and validation of enrollment functions, as well as field testing to evaluate: 1) improved enrollment efficiency using the app for rare kidney diseases; and 2) improve access to clinical trials in traditionally underserved communities including urban, exurban, and rural areas. During Phase II we will focus on optimizing the digital infrastructure of the app to ensure reliable communication and compliance with regulations regarding patient privacy. Discrete element search functions will be developed, allowing clinical trial sponsors to target narrowly defined patient populations, essential for development of therapeutics against rare diseases. Validation studies will be undertaken to finalize the commercial version of the app and a subsequent study representing 400 participating physicians will be performed to evaluate the ability of this new technology and process to improve clinical trial enrollment. Data from these evaluations will provide compelling evidence to Arkana’s customers, the sponsors of kidney disease clinical trials, that pathology-directed patient recruitment aided by technology can address the unmet need for efficient and targeted clinical trial enrollment.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	NEPHROPATHOLOGY ASSOCIATES, PLC	10810 EXECUTIVE CENTER DR STE 100	LITTLE ROCK	AR	72211	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	8/8/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $950,283 )
2024	2024	NEPHROPATHOLOGY ASSOCIATES, PLC	10810 EXECUTIVE CENTER DR STE 100	LITTLE ROCK	AR	72211	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	8/20/2024	NON-COMPETING CONTINUATION	$950,283
2024	2023	NEPHROPATHOLOGY ASSOCIATES, PLC	10810 EXECUTIVE CENTER DR STE 100	LITTLE ROCK	AR	72211	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/26/2023	NEW	$0
														Subtotal = $950,283

Issue Date FY: 2023 ( Subtotal = $976,283 )
2023	2023	NEPHROPATHOLOGY ASSOCIATES, PLC	10810 EXECUTIVE CENTER DR STE 100	LITTLE ROCK	AR	72211	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/15/2023	NEW	$976,283
														Subtotal = $976,283

Grand Total All Awards = $1,926,566

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A proprietary digital platform for precision patient identification and enrollment of clinical trials for rare kidney diseases

Award Number: R44DK138688

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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