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Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery

NCT05126303 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2024-05-16

Study results available
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Summary

This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo.

Conditions

Interventions

DRUG

RMC-035

Concentrate for Solution for Infusion

DRUG

Placebo

Concentrate for Solution for Infusion

Sponsors & Collaborators

  • Guard Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Tobias Agervald, MD · Guard Therapeutics

  • Alexander Zarbock, MD · Muenster University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-04-15
Completion
2023-07-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05126303 on ClinicalTrials.gov