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A Study to Evaluate Efficacy and Safety of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02610283
First Posted: November 20, 2015
Last Update Posted: June 28, 2017
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.
Information provided by (Responsible Party):
Quark Pharmaceuticals
  Purpose
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.

Condition Intervention Phase
Acute Kidney Injury Drug: QPI-1002 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI Following Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Quark Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of subjects developing AKI as defined by the AKIN criteria [ Time Frame: Baseline through Day 5 ]

Secondary Outcome Measures:
  • Proportion of subjects developing at least on of the following events: death, needing renal replacement therapy (RRT) during the 90-day post-operative period, or having a ≥ 25% reduction in SCr based eGFR at the Day 90 visit [ Time Frame: Baseline through Day 90 ]

Enrollment: 341
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: QPI-1002
QPI-1002 Injection, single dose
Drug: QPI-1002
IV injection
Placebo Comparator: Placebo
isotonic saline
Drug: Placebo
isotonic saline

Detailed Description:
This is a randomized, double-blind, placebo-controlled, Phase 2 trial to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have the ability to understand the requirements of the study, are able to provide written informed consent and are willing and able to comply with the requirements of the study
  • Male or female, age ≥ 45 years old.
  • Have stable renal function per Investigator assessment and no known increase in serum creatinine of ≥ 0.3 mg/dL during preceding 4 weeks.
  • Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB:

    • Combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery) and at least 1 AKI Risk Factor;
    • Surgery of more than one cardiac valve (valve surgery) and at least 1 AKI Risk Factor;
    • Surgery of the aortic root or ascending part of the aorta, or in combination with the aortic valve, and at least 1 AKI Risk Factor; circulatory arrest is not excluded;
    • Aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery and at least 1 AKI Risk Factor; circulatory arrest is not excluded;
    • If only CABG or single valve surgery, subjects are required to have at least 2 AKI Risk Factors:

AKI Risk Factors:

  • Age ≥ 70 years
  • eGFR ≤ 60 ml/min/1.73m2 by CKD-EPI formula at Screening.
  • Diabetes (Type 1 or 2), requiring at least 1 oral hypoglycemic agent or insulin
  • Proteinuria ≥ 0.3g/d, spot UPCR ≥ 0.3g/gm or urine dip stick ≥ +2
  • History of congestive heart failure requiring hospitalization

Exclusion Criteria:

  • Have an eGFR ≤ 20 mL/min/1.73 m2
  • Subjects with an eGFR ≤ 60 mL/min/1.73 m2 requiring intravascular iodinated contrast within 48 hours of the day of surgery. However, subjects may be included if the post contrast increase in serum creatinine is < 0.3 mg/dl in at least 2 serum creatinine evaluations performed not less than 36 hours apart.
  • Have a history of any organ or cellular transplant which requires active immunosuppressive treatment which can interfere with kidney function
  • Emergent surgeries, including aortic dissection, and major congenital heart defects
  • Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR) or single vessel, mid-CAB off-pump surgeries or left ventricular assist device (LVAD) implantation
  • Have participated in an investigational drug study in the last 30 days
  • Have a known allergy to or had participated in a prior study with siRNA
  • Have a history of human immunodeficiency virus (HIV) infection
  • Have known active Hepatitis B (HBV) (Note: Subjects with a serological profile suggestive of clearance, or prior antiviral treatment of HBV infection may be enrolled)
  • Are HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled.)
  • Have had cardiogenic shock or hemodynamic instability within the 24 hours prior to surgery, requiring inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP)
  • Have required any of the following within a week prior to cardiac surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, left ventricular assist device (LVAD), other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary).
  • Have required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
  • Have ongoing sepsis or history of sepsis within the past 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension
  • Have total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) at time of screening
  • Have Child Pugh Class A liver disease with ALT/AST above the upper limit of normal or Class B or higher. (This criterion is only applicable in a patient population with underlying chronic liver disease, i.e., cirrhosis.)
  Contacts and Locations
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): NCT02610283


  Show 36 Study Locations
Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
Study Director: Elizabeth Squiers, M.D. Quark Pharmaceuticals
  More Information

Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02610283     History of Changes
Other Study ID Numbers: QRK209
First Submitted: November 18, 2015
First Posted: November 20, 2015
Last Update Posted: June 28, 2017
Last Verified: June 2017

Keywords provided by Quark Pharmaceuticals:
AKI

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases