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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Drug: teprasiran
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QPI-1002<br>QPI-1002 Injection, Single dose | Drug: teprasiran<br>* IV injection<br>* Other names: QPI-1002;|
| Placebo Comparator: Placebo<br>isotonic saline | Drug: Placebo<br>* isotonic saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects through day 90 who develop major adverse kidney events |  | Baseline through day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery |  | Baseline through day 5 | 
| Renal function as estimated by glomerular filtration rate |  | Baseline through Day 90 | 
| Proportion of subjects who die or initiate dialysis through day 90 |  | Baseline through day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAKE, AKI