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

NCT06475274 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 24-ROS-07
• Study Type: interventional
• Target: 170
• Locations: 4 countries
• Sites: 19

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo)

  Difference in estimated glomerular filtration rate (eGFR) at Day 90 (end of study) compared to baseline.

  90 days

Secondary Outcomes (1)

• Occurrence of MAKE (and each MAKE component) at Day 90

  90 days

Other Outcomes (12)

• Change from baseline in eGFR at Day 90 (the two arms of RMC-035 compared separately against placebo)

  90 days

• Occurrence of MAKE (and each MAKE component) at Day 60

  60 days

• Change from baseline in eGFR at Day 7 (the two arms of RMC-035 compared pooled and separately against placebo)

  7 days

Study Arms (3)

RMC-035 high-dose

EXPERIMENTAL

RMC-035 60 mg

Drug: RMC-035

RMC-035 low-dose

EXPERIMENTAL

RMC-035 30 mg

Drug: RMC-035

Placebo

PLACEBO COMPARATOR

Placebo (tris-buffer)

Drug: Placebo

Interventions

RMC-035 DRUG

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

RMC-035 high-dose; RMC-035 low-dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eGFR ≥30 ml/min/1.73m2
• Scheduled for non-emergent surgery of any of the following types, with use of cardiopulmonary bypass (CPB): coronary artery bypass grafting (CABG), valve surgery, ascending aorta aneurysm surgery
• Risk factors for acute kidney injury are present
• Participant capable of providing written informed consent
• Participant agrees to study restrictions such as not to take part in another interventional study, use contraception and not donate ova or sperm

You may not qualify if:

• Any medical condition that makes the participant unsuitable
• Scheduled for emergent surgeries
• Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries
• Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation
• Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices such as intraaortic balloon pumping (IABP) within 24 hours prior to surgery
• Requires any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support.
• Diagnosed with AKI prior to surgery
• Requires cardiopulmonary resuscitation prior to surgery
• Ongoing sepsis or an untreated diagnosed clinically significant infection
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3.0 times the upper limit of normal (ULN).
• Total bilirubin ≥2.0 time ULN
• History of solid organ transplantation
• History of renal replacement therapy
• Severe allergic asthma
• Chronic immunosuppressive treatment that may have an impact on kidney function

Sponsors & Collaborators

• Guard Therapeutics AB: lead

Study Sites (19)

Research site 4

Montreal, Canada

Location

Research site 5

Montreal, Canada

Location

Research site 2

Québec, Canada

Location

Research site 3

Saint John, Canada

Location

Research site 1

Toronto, Canada

Location

Research site 1

Hradec Králové, Czechia

Location

Research site 2

Prague, Czechia

Location

Research site 5

Dresden, Germany

Location

Research site 3

Essen, Germany

Location

Research site 6

Giessen, Germany

Location

Research site 4

Halle, Germany

Location

Research site 2

München, Germany

Location

Research site 1

Münster, Germany

Location

Research site 3

Barcelona, Spain

Location

Research site 4

Córdoba, Spain

Location

Research site 1

Madrid, Spain

Location

Research site 2

Madrid, Spain

Location

Research site 6

Pamplona, Spain

Location

Research site 5

Santiago de Compostela, Spain

Location

Related Publications (1)

• Zarbock A, Strauss C, Laflamme M, Myjavec A, Bohm J, Burkert J, Mazer CD, de Varennes B, Iglesias AG, Matschke K, Larsson TE, Reusch M; POINTER study group. POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery. Trials. 2025 Oct 28;26(1):449. doi: 10.1186/s13063-025-09124-x.

  PMID: 41152991 DERIVED

Study Officials

• Michael Reusch, MD

  Guard Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: August 26, 2024
• Primary Completion: September 11, 2025
• Study Completion: September 11, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-10

Locations

CA (5); CZ (2); DE (6); ES (6)