TerminatedPhase 3

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

Stopped: Study completed day 90 for primary endpoint but was terminated early for one year follow up due to results not meeting efficacy outcome at Day 90.

United States1,043 participantsStarted 2018-06-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of subjects through day 90 who develop major adverse kidney events

Timeframe: Baseline through day 90

Trial details

NCT IDNCT03510897

SponsorQuark Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-14

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