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

Information

  • Research Project
  • 9141919
  • ApplicationId
    9141919
  • Core Project Number
    R43DK109870
  • Full Project Number
    1R43DK109870-01
  • Serial Number
    109870
  • FOA Number
    PA-13-052
  • Sub Project Id
  • Project Start Date
    6/10/2016 - 8 years ago
  • Project End Date
    5/31/2017 - 7 years ago
  • Program Officer Name
    MOXEY-MIMS, MARVA M.
  • Budget Start Date
    6/10/2016 - 8 years ago
  • Budget End Date
    5/31/2017 - 7 years ago
  • Fiscal Year
    2016
  • Support Year
    01
  • Suffix
  • Award Notice Date
    6/13/2016 - 8 years ago
Organizations

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.

IC Name
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
  • Activity
    R43
  • Administering IC
    DK
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    218241
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    847
  • Ed Inst. Type
  • Funding ICs
    NIDDK:218241\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    KYPHA, INC.
  • Organization Department
  • Organization DUNS
    832251537
  • Organization City
    SAINT LOUIS
  • Organization State
    MO
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    63108
  • Organization District
    UNITED STATES