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A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Exploring a new iron-based treatment for high phosphorus levels.

Recruiting
18 years and older
All
Phase 3
A Study of a Novel Iron-based Phosphate Binder AP301 This study tests a new drug, AP301, for patients on dialysis with high phosphate levels in their blood. High phosphate can cause health problems, especially in people with kidney issues. Dialysis is a treatment that helps clean the blood when kidneys aren't working well. The study looks to see if AP301 can lower phosphate levels and check its effects on calcium in the blood, a hormone called parathyroid hormone, and overall quality of life, especially for Chinese patients. Participants will stop other phosphate-lowering drugs and take AP301 or a similar-looking substance three times daily over several weeks. The study lasts for a total of 35 weeks, with dosage adjusted according to each patient's needs.
  • Duration: 35 weeks of treatment.
  • Visits: Regular follow-ups and adjustments as needed.
  • Risks: Possible side effects or discomfort from AP301.
This study is an option for adults on dialysis for at least 3 months, with specific blood phosphate levels, and no plans for kidney transplants or certain surgeries. Participants should not have severe allergies or significant stomach issues.
Study details
    Hyperphosphatemia
    Chronic Kidney Disease
    Receiving Dialysis
    ESRD (End-Stage Renal Disease)
    Dialysis

NCT06933472

Alebund Pharmaceuticals

28 June 2025

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