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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.
Full description
This is a randomized, double-blind, placebo-controlled, Phase 2 trial to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.
Enrollment
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Volunteers
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.
Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB:
AKI Risk Factors:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
341 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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