Phase 2a Study of JMKX003002 Tablets for Treating High Phosphorus in Adults with End-Stage Kidney Disease on Hemodialysis

What this Trial Is About

This trial investigates the efficacy and safety of a drug called JMKX003002 in patients with end-stage renal disease ESRD who are on hemodialysis and have hyperphosphatemia, which means elevated phosphate levels in the blood. It is a Phase 2a, multicenter, randomized, open-label study comparing JMKX003002 to an active drug called Sevelamer carbonate. The study is sponsored by Jemincare and aims to evaluate how well JMKX003002 lowers serum phosphorus levels over four weeks. Participants will be randomly assigned to one of three groups one receiving JMKX003002 once daily, another receiving JMKX003002 twice daily, and a third group receiving Sevelamer carbonate three times daily. All treatments are given as oral tablets for a duration of four weeks. The study does not use blinding, so participants and researchers know which treatment is given. During the study, participants will undergo assessments focused on measuring serum phosphorus levels to evaluate the drugs effectiveness. The main outcome is the change in serum phosphorus after four weeks of treatment. Participants must be on stable hemodialysis schedules before enrollment and will be monitored for safety and treatment adherence throughout the study period, which starts in late 2024 and ends in September 2025.

Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia