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

Conditions

• Chronic Kidney Disease, Receiving Dialysis
• Dialysis
• ESRD (End-Stage Renal Disease)
• Hyperphosphatemia

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AP301 — DRUG
  Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
• AP301 Low Dose — DRUG
  Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g

Study Details

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lower blood phosphate levels? * Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level? * What discomfort or medical problem do the patients have when taking AP301? * Does AP301 improve quality of life in Chinese patients? The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate. In the study, the patients will experience the following stages in a chronicle order: * Stop all using blood phosphate-lowering drugs, * Take AP301 or the comparator three times a day for 8 weeks, * Take AP301 three times a day for 24 weeks, and * Take AP301 or the comparator three times a day for 3 weeks. In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment. If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.

Key Dates

Start date

Jun 13, 2025

Status verified

Jun 2025

Primary completion

Jun 20, 2026

Completion

Jan 10, 2027

Study Design

Enrollment

264 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AP301
  A blood phosphate-lowering medication containing iron
• Experimental: AP301 Low Dose
  A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective

Primary Outcome Measure

Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups [ Time Frame: From Baseline to the end of Week 8 ]

Central Contacts

• Weifeng Zhang, M.D.
  +8618602184576
  [email protected]
• Bobby Zang
  +8613661683813
  [email protected]

Locations (19)

Find similar trials in Granada Hills, CA

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