A Study to Evaluate Efficacy and Safety of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
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| ClinicalTrials.gov Identifier: NCT02610283 |
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Recruitment Status :
Completed
First Posted : November 20, 2015
Last Update Posted : January 10, 2019
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Sponsor:
Quark Pharmaceuticals
Information provided by (Responsible Party):
Quark Pharmaceuticals
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Surgery
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: QPI-1002
QPI-1002 Injection, single dose
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Drug: QPI-1002
IV injection |
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Placebo Comparator: Placebo
isotonic saline
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Drug: Placebo
isotonic saline |
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 ]
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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.
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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.)
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
Locations
Show 36 study locations
Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
| Study Director: | Elizabeth Squiers, M.D. | Quark Pharmaceuticals |
| Responsible Party: | Quark Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02610283 |
| Other Study ID Numbers: |
QRK209 |
| First Posted: | November 20, 2015 Key Record Dates |
| Last Update Posted: | January 10, 2019 |
| Last Verified: | April 2018 |
Keywords provided by Quark Pharmaceuticals:
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AKI |
Additional relevant MeSH terms:
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Acute Kidney Injury Wounds and Injuries Renal Insufficiency Kidney Diseases Urologic Diseases |