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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

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ClinicalTrials.gov Identifier: NCT03510897
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals

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: QPI-1002 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1088 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 : May 25, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: QPI-1002
QPI-1002 Injection, Single dose
Drug: QPI-1002
IV injection

Placebo Comparator: Placebo
isotonic saline
Drug: Placebo
isotonic saline




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 ]


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

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


Contacts
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Contact: Quark Pharma Clinical Trials 510-402-4020 ClinicalTrials@quarkpharma.com

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Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
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Study Director: John Holman, MD.,PhD. Quark Pharmaceuticals

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Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03510897     History of Changes
Other Study ID Numbers: QRK309
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: April 2018

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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