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A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery

NCT04829916 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-04-23

Study results available
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Summary

The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.

Conditions

  • Acute Kidney Injury (AKI)

Interventions

DRUG

RMC-035

Multiple dosing during 48 hours following cardiac surgery

DRUG

Placebo

Multiple dosing during 48 hours following cardiac surgery

Sponsors & Collaborators

  • Guard Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Tobias Agervald, MD PhD · Guard Therapeutics AB

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2021-07-15
Completion
2021-07-15

Countries

  • Germany

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 NCT04829916 on ClinicalTrials.gov