Finding the best dose of RMC-035 to protect kidney function after heart surgery

A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Study to Evaluate the Efficacy on Renal Function and Safety of RMC-035 in Participants At High Risk for Kidney Injury Following Open-Chest Cardiac Surgery

This study is testing different doses of a drug called RMC-035 to see if it can help protect kidney function in adults at high risk of kidney injury after heart surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 161 (estimated)
• Ages: 18 Years to 84 Years
• Sex: All
• Sponsor: Guard Therapeutics AB (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 19 sites (Montreal and 18 other locations)
• Trial ID: NCT06475274 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the optimal dose of RMC-035 for protecting long-term kidney function in adults undergoing open-chest cardiac surgery who are at high risk for kidney injury. Participants will receive either a high dose, low dose, or placebo of RMC-035 at specific times during and after their surgery. The study will assess kidney function and safety through various checkups and tests during the hospital stay and follow-up visits at 60 and 90 days post-surgery. The primary focus is to evaluate whether RMC-035 can improve kidney outcomes compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for non-emergent open-chest cardiac surgeries with risk factors for acute kidney injury and an eGFR of 30 ml/min/1.73m2 or higher.

Not a fit: Patients scheduled for emergent surgeries or those with certain medical conditions that make them unsuitable for the trial may not benefit.

Why it matters

Potential benefit: If successful, this study could lead to improved kidney protection for patients undergoing high-risk cardiac surgeries.

How similar studies have performed: While this approach is focused on a specific drug and population, similar studies have shown promise in protecting kidney function during cardiac surgeries.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Where this trial is running

Montreal and 18 other locations

• Research site 4 — Montreal, Canada (RECRUITING)
• Research site 5 — Montreal, Canada (RECRUITING)
• Research site 2 — Quebec, Canada (RECRUITING)
• Research site 3 — Saint John, Canada (RECRUITING)
• Research site 1 — Toronto, Canada (RECRUITING)
• Research site 1 — Hradec Kralove, Czech Republic (RECRUITING)
• Research site 2 — Prague, Czech Republic (RECRUITING)
• Research site 5 — Dresden, Germany (RECRUITING)
• Research site 3 — Essen, Germany (RECRUITING)
• Research site 6 — Giessen, Germany (RECRUITING)
• Research site 4 — Halle, Germany (RECRUITING)
• Research site 2 — Muenchen, Germany (RECRUITING)
• Research site 1 — Muenster, Germany (RECRUITING)
• Research site 3 — Barcelona, Spain (RECRUITING)
• Research site 4 — Cordoba, Spain (RECRUITING)
• Research site 1 — Madrid, Spain (RECRUITING)
• Research site 2 — Madrid, Spain (RECRUITING)
• Research site 6 — Pamplona, Spain (RECRUITING)
• Research site 5 — Santiago de Compostela, Spain (RECRUITING)

Study contacts

• Study coordinator: Sara Thuresson

Conditions: Kidney Injury Following Open-Chest Cardiac Surgery