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Reducing time, sample handling, and staff requirements for complement activation monitoring in clinical trials

Award Number: R43DK109870
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: 06/10/2016
PERIOD OF PERFORMANCE END DATE: 05/31/2017

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Reducing time, sample handling, and staff requirements for complement activation monitoring in clinical trials - ¿ DESCRIPTION (provided by applicant): Despite overwhelming evidence that the complement system is involved in kidney and cardiovascular outcomes, stringent technical requirements limit its inclusion in clinical trials and diagnostics. Current protocols require careful sample collectin, immediate freezing, and shipping to only a few specialized labs. As a result, while complement system proteins C3 and C4 are routinely measured in autoimmune disease clinics, proteolytically activated split products known to mediate active inflammatory and autoimmune processes are rarely assessed. Kypha Inc. is developing an integrated point-of-care (POC) platform to make reliable complement data more accessible to clinical trials and diagnostic applications. These efforts are timely due to recent therapeutic development focused on anti-inflammatory strategies including complement inhibition for extracorporeal therapies (such as hemodialysis), autoimmunity, transplant rejection, and other conditions. Milestones in this Phase I proposal will demonstrate the feasibility of using advanced multiplex quantitative lateral flow assays in the point of care as a solution that decreases the resources required to measure complement activation and inflammation in clinical trials, paving the way for their full utility inthe diagnosis and management of acute and chronic renal and vascular inflammatory diseases.


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: 2018 ( Subtotal = $0 )
2018	2016	KYPHA INC.	4320 FOREST PARK AVE STE 303	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	11/17/2017	NEW	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $218,241 )
2016	2016	KYPHA INC	4320 FOREST PARK AVENUE	SAINT LUIS	MO	63108		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	6/28/2016	NEW	$0
2016	2016	KYPHA INC	4320 FOREST PARK AVENUE	SAINT LUIS	MO	63108		USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/13/2016	NEW	$218,241
														Subtotal = $218,241

Grand Total All Awards = $218,241

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Reducing time, sample handling, and staff requirements for complement activation monitoring in clinical trials

Award Number: R43DK109870

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: 06/10/2016

PERIOD OF PERFORMANCE END DATE: 05/31/2017

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