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Trial record 2 of 3 for:    QPI-1002 AKI

QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03510897
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 18, 2018
First Posted Date  ICMJE April 27, 2018
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE May 25, 2018
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
Proportion of subjects through day 90 who develop major adverse kidney events [ Time Frame: Baseline through day 90 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery [ Time Frame: Baseline through day 5 ]
  • Renal function as estimated by glomerular filtration rate [ Time Frame: Baseline through Day 90 ]
  • Proportion of subjects who die or initiate dialysis through day 90 [ Time Frame: Baseline through day 90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
Official Title  ICMJE A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
Brief Summary This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.
Detailed Description This is a randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events in subjects at high risk for acute kidney injury following cardiac surgery. Subjects will be dosed with active drug or placebo after the completion of cardiovascular surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiac Surgery
Intervention  ICMJE
  • Drug: QPI-1002
    IV injection
  • Drug: Placebo
    isotonic saline
Study Arms  ICMJE
  • Active Comparator: QPI-1002
    QPI-1002 Injection, Single dose
    Intervention: Drug: QPI-1002
  • Placebo Comparator: Placebo
    isotonic saline
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
1088
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Male or female, age ≥ 18 years old
  • At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:

    • Reduced renal function
    • Diabetes with ongoing insulin treatment
    • Albuminuria
  • Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest

Key Exclusion Criteria:

  • Emergent surgeries, including aortic dissection, and major congenital heart defects
  • Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB for subjects <45 years old is allowed.)
  • Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is inserted or anticipated
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Quark Pharma Clinical Trials 510-402-4020 ClinicalTrials@quarkpharma.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   France,   Germany,   New Zealand,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03510897
Other Study ID Numbers  ICMJE QRK309
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quark Pharmaceuticals
Study Sponsor  ICMJE Quark Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Holman, MD.,PhD. Quark Pharmaceuticals
PRS Account Quark Pharmaceuticals
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP