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

Launched by GUARD THERAPEUTICS AB · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new drug called RMC-035 to see if it can help protect kidney function in adults undergoing open-chest heart surgery, especially those at high risk of kidney problems. The main goals are to find the best dose of RMC-035 and to check if it is safe for patients. Participants will receive three doses of the drug or a placebo (a harmless substance with no active ingredients) during their hospital stay, and they will have extra check-ups and tests to monitor their kidney health.

To be eligible for this study, participants must be scheduled for certain types of heart surgeries and show signs that they are at risk for kidney injury. They should also be able to give their consent to join the trial. During the study, patients can expect to be closely monitored in the hospital and return for follow-up visits two and three months after surgery. It’s important to note that this trial is currently recruiting participants, so those who qualify may have the opportunity to contribute to important research that could help improve kidney health after heart surgery.

Gender

ALL

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