Assessing Pharmacokinetics and Safety of Therapeutic Alpha-1-Microglobulin in First-in-Human Kidney Transplantation: A Noncomparative Open-Label Multiple-Dose Phase 1b Study.

ABSTRACT:

Background

RMC-035 is a modified version of alpha-1-microglobulin, an endogenous protein developed as a renoprotective agent. Its intended use is to reduce the risk of irreversible loss of kidney function in cardiac surgery patients and to reduce delayed graft function in kidney transplant recipients. This first-in-human study aimed to evaluate the pharmacokinetics and safety of RMC-035 in kidney transplant recipients.

Methods

Eight living-donor kidney transplant recipients were included in 2 dose cohorts. The study drug RMC-035 was administered starting with the first dose during transplantation. Four additional doses were administered once daily following transplantation. In the first cohort, all 5 doses of RMC-035 were equal, whereas in the second cohort, the last 3 doses

SUBMITTER: Nordstrom JEA 

PROVIDER: S-EPMC11554354 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature