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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
170
Protein, a recombinant variant of A1M. Concentrate for solution for infusion.
Identical to RMC-035 intervention devoid of the active substance.
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
...and 9 more locations
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.
Time frame: 90 days
Occurrence of MAKE (and each MAKE component) at Day 90
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.
Time frame: 90 days
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