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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Acute Kidney Injury	Drug: QPI-1002; Drug: Placebo	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	341 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 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
Study Start Date :	December 2015
Actual Primary Completion Date :	February 2018
Actual Study Completion Date :	April 2018

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Proportion of subjects developing AKI as defined by the AKIN criteria [ Time Frame: Baseline through Day 5 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	45 Years and older (Adult, Older Adult)
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

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Sponsors and Collaborators

Quark Pharmaceuticals

Investigators

Study Director:	Elizabeth Squiers, M.D.	Quark Pharmaceuticals

More Information

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Responsible Party:	Quark Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT02610283 History of Changes
Other Study ID Numbers:	QRK209
First Posted:	November 20, 2015
Last Update Posted:	April 26, 2018
Last Verified:	April 2018

Keywords provided by Quark Pharmaceuticals:

AKI

Additional relevant MeSH terms:

Wounds and Injuries; Acute Kidney Injury; Renal Insufficiency; Kidney Diseases; Urologic Diseases