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A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia

Testing AP306 for safety and effectiveness in dialysis patients with high phosphate.

Recruiting
18 years and older
All
Phase 2

This study is testing a new drug called AP306 for adults with hyperphosphatemia (high phosphate levels in the blood) who are on hemodialysis (a treatment that cleans the blood when kidneys can't). Hyperphosphatemia is common in people with kidney problems and can lead to heart issues and other health problems.

AP306 is designed to block phosphate from being absorbed in the stomach, which might help control hyperphosphatemia. The study is randomized, double-blind, and placebo-controlled, meaning participants are randomly given either the drug or a non-active substance (placebo) without knowing which one they’re getting. It lasts 8 weeks.

  • The study is 8 weeks long with daily dosing.
  • Participants must have stable dialysis for at least 12 weeks.
  • Some people can't join, like those pregnant or with certain health issues.

Participants must sign a consent form and meet specific health criteria. They also need to agree to use effective birth control if necessary. If you're considering joining, make sure all your medications and health conditions fit the study rules.

Study details
    Hyperphosphatemia
    Chronic Kidney Disease Requiring Chronic Dialysis
    End Stage Renal Disease on Dialysis

NCT06712654

R1 Therapeutics

11 July 2026

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