A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery
- Conditions
- Kidney Injury Following Open-Chest Cardiac Surgery
- Interventions
- Drug: Placebo
- Registration Number
- NCT06475274
- Lead Sponsor
- Guard Therapeutics AB
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 161
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RMC-035 high-dose RMC-035 RMC-035 60 mg RMC-035 low-dose RMC-035 RMC-035 30 mg Placebo Placebo Placebo (tris-buffer)
- Primary Outcome Measures
Name Time Method Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo) 90 days Difference in estimated glomerular filtration rate (eGFR) at Day 90 (end of study) compared to baseline.
- Secondary Outcome Measures
Name Time Method Occurrence of MAKE (and each MAKE component) at Day 90 90 days Occurrence of major adverse kidney events (MAKE), consisting of the following components: death, any new renal replacement therapy (RRT) after surgery, or sustained loss of kidney function, defined as a 25% or greater decline in eGFR, until Day 90.
Trial Locations
- Locations (6)
Research site 4
🇪🇸Cordoba, Spain
Research site 5
🇪🇸Santiago de Compostela, Spain
Research site 2
🇪🇸Madrid, Spain
Research site 3
🇪🇸Barcelona, Spain
Research site 1
🇪🇸Madrid, Spain
Research site 6
🇪🇸Pamplona, Spain