R1 Therapeutics
This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
Hyperphosphatemia, one of the most common complications of advanced chronic kidney disease, becomes increasingly prevalent as kidney function declines and is found almost universally in patients with end-stage kidney disease requiring dialysis. Hyperphosphatemia is an independent risk factor for cardiovascular outcomes, fractures, and mortality in patients with chronic kidney disease, especially in patients receiving dialysis. AP306 is a pan-phosphate transporter inhibitor that may stop phosphate absorption in the gut, controlling hyperphosphatemia. This is a randomized, double-blind, placeb…
Important Inclusion Criteria: * Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study * Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per week for at least 12 weeks before signing the ICF, and does not plan to change in the study * Who has a blood phosphate level within the study-required range * Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening or any documented value…
AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.