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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03510897
Recruitment Status : Terminated (Study completed day 90 for primary endpoint but was terminated early for one year follow up due to results not meeting efficacy outcome at Day 90.)
First Posted : April 27, 2018
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: teprasiran Drug: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1043 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 29, 2018
Actual Primary Completion Date : October 14, 2020
Actual Study Completion Date : April 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: QPI-1002
QPI-1002 Injection, Single dose
 Drug: teprasiran
IV injection
Other Name: QPI-1002
Placebo Comparator: Placebo
isotonic saline
 Drug: Placebo
isotonic saline


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects through day 90 who develop major adverse kidney events [ Time Frame: Baseline through day 90 ]

Secondary Outcome Measures :
  1. Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery [ Time Frame: Baseline through day 5 ]
  2. Renal function as estimated by glomerular filtration rate [ Time Frame: Baseline through Day 90 ]
  3. Proportion of subjects who die or initiate dialysis through day 90 [ Time Frame: Baseline through day 90 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03510897


Locations
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Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
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Study Director: Nitsan Halevy, MD Quark Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03510897    
Other Study ID Numbers: QRK309
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Quark Pharmaceuticals:
MAKE
AKI