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

Quark Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Cardiac Surgery

Treatments: Drug: Placebo; Drug: teprasiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT03510897

QRK309

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,043 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,043 participants in 2 patient groups, including a placebo group

QPI-1002

Active Comparator group

Description:

QPI-1002 Injection, Single dose

Treatment:

Drug: teprasiran

Placebo

Placebo Comparator group

Description:

isotonic saline

Treatment:

Drug: Placebo