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

NCT03510897 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1043

Last updated 2021-07-16

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery

Interventions

DRUG

teprasiran

IV injection

DRUG

Placebo

isotonic saline

Sponsors & Collaborators

  • Quark Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Nitsan Halevy, MD · Quark Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-29
Primary Completion
2020-10-14
Completion
2021-04-12
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510897 on ClinicalTrials.gov