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A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
NCT06933472 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG AP301
- DRUG AP301 Low Dose
Study Locations (20)
Texas
- Dallas Renal Group - Dallas — Dallas
- US Renal Care - Bluebonnet — Fort Worth
- Gamma Medical Research — McAllen
- US Renal Care - South San Antonio — San Antonio
- US Renal Care - Hill Country — San Antonio
California
- Renal Consultants Medical Group — Granada Hills
- North America Research Institute - San Dimas — San Dimas
- North America Research Institute - San Dimas — San Dimas
Mississippi
- Nephrology Associates, P.C. - Columbus — Columbus
- Nephrology & Hypertension Associates Ltd - Tupelo — Tupelo
New York
- US Renal Care - West Cheektowaga — Cheektowaga
- NY Kidney & Hypertension Medicine — Ridgewood
Colorado
- Rocky Mountain Kidney Care - Lone Tree — Lone Tree
Connecticut
- PACT Kidney Care - Orange — Orange
Florida
- US Renal Care - Fort Myers South — Fort Myers
Georgia
- Nephrology & Hypertension Specialists — Dalton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2025-06-13 |
| Est. Completion | 2027-01-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06933472
The ClinicalTrials.gov registry entry for NCT06933472 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alebund Pharmaceuticals, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Hyperphosphatemia appearing as the primary indexed condition, and to 2 interventions — of which AP301 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06933472 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Mississippi. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06933472 about?
NCT06933472 is a clinical study titled "A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China". 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...
What is the current status of trial NCT06933472?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2025-06-13. Estimated completion is 2027-01-10.
What conditions does trial NCT06933472 study?
This clinical trial studies the following conditions: Hyperphosphatemia, Dialysis, ESRD (End-Stage Renal Disease), Chronic Kidney Disease, Receiving Dialysis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06933472?
The interventions under investigation include: AP301 (DRUG), AP301 Low Dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06933472?
This trial is sponsored by Alebund Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06933472 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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