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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03510897

Enrollment

1043

Registered

2018-04-27

Start date

2018-06-29

Completion date

2021-04-12

Last updated

2021-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

MAKE, AKI

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.

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.

Interventions

DRUGteprasiran

IV injection

DRUGPlacebo

isotonic saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects through day 90 who develop major adverse kidney events	Baseline through day 90

Secondary

Measure	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

Countries

Australia, Austria, Belgium, Canada, Czechia, France, Germany, New Zealand, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026