A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery
NCT ID: NCT06475274
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2024-08-26
2025-09-11
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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RMC-035 high-dose
RMC-035 60 mg
RMC-035
Protein, a recombinant variant of A1M. Concentrate for solution for infusion.
RMC-035 low-dose
RMC-035 30 mg
RMC-035
Protein, a recombinant variant of A1M. Concentrate for solution for infusion.
Placebo
Placebo (tris-buffer)
Placebo
Identical to RMC-035 intervention devoid of the active substance.
Interventions
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RMC-035
Protein, a recombinant variant of A1M. Concentrate for solution for infusion.
Placebo
Identical to RMC-035 intervention devoid of the active substance.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
* Current enrolment or past recent participation in any other clinical study involving an investigational study treatment
* Previously treatment of RMC-035
* Sensitivity to any of the study interventions, or components thereof
18 Years
84 Years
ALL
No
Sponsors
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Guard Therapeutics AB
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Reusch, MD
Role: STUDY_DIRECTOR
Guard Therapeutics
Locations
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Research site 4
Montreal, , Canada
Research site 5
Montreal, , Canada
Research site 2
Québec, , Canada
Research site 3
Saint John, , Canada
Research site 1
Toronto, , Canada
Research site 1
Hradec Králové, , Czechia
Research site 2
Prague, , Czechia
Research site 5
Dresden, , Germany
Research site 3
Essen, , Germany
Research site 6
Giessen, , Germany
Research site 4
Halle, , Germany
Research site 2
München, , Germany
Research site 1
Münster, , Germany
Research site 3
Barcelona, , Spain
Research site 4
Córdoba, , Spain
Research site 1
Madrid, , Spain
Research site 2
Madrid, , Spain
Research site 6
Pamplona, , Spain
Research site 5
Santiago de Compostela, , Spain
Countries
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References
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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.
Other Identifiers
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24-ROS-07
Identifier Type: -
Identifier Source: org_study_id
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