A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.… (NCT06933472) | Clinical Trial Compass
RecruitingPhase 3
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
United States, China264 participantsStarted 2025-06-13
Plain-language summary
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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial testing AP301 as an iron-based phosphate binder, what do we know so far about how it compares to the phosphate binders I'm already taking or might take — and is there a reason to try a new option like this over something already approved?
2The trial is measuring changes in serum phosphate levels between a standard dose and a low dose of AP301 — does my current phosphate level put me in a range where either of those doses might make sense for my situation?
3Since I'm already on dialysis, how would joining this trial affect my current dialysis schedule and medication routine — would I need extra clinic visits or blood tests on top of what I already do?
4Because this study is running in both the U.S. and China, could you help me find out which specific U.S. sites are recruiting and whether any are close enough for me to realistically participate?
5If I join this trial and end up in the lower-dose group, is there a risk my phosphate levels might not be controlled well enough during the study, and what's the plan if that happens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups