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A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery

NCT06475274 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-10-02

No results posted yet for this study

Summary

The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury. It will also learn about the safety of RMC-035. The main question it aims to answer is:

* Does RMC-035 protect the function of kidneys after surgery?
* Is RMC-035 safe?

Researchers will compare RMC-035 in high dose, RMC-035 in low dose and placebo to see if

* Kidney function better for participants treated with any of the RMC-035 doses?
* What medical problems do participants have when receiving RMC-035?

Participants will

* Receive 3 doses of RMC-035 or placebo: at the beginning of surgery, end of surgery and 24h after surgery
* Have extra checkups and tests during their hospital stay
* Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests

Conditions

  • Kidney Injury Following Open-Chest Cardiac Surgery

Interventions

DRUG

RMC-035

Protein, a recombinant variant of A1M. Concentrate for solution for infusion.

DRUG

Placebo

Identical to RMC-035 intervention devoid of the active substance.

Sponsors & Collaborators

  • Guard Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Michael Reusch, MD · Guard Therapeutics

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
2024-08-26
Primary Completion
2025-09-11
Completion
2025-09-11
FDA Drug
Yes

Countries

  • Canada
  • Czechia
  • Germany
  • Spain

Study Locations

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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 NCT06475274 on ClinicalTrials.gov