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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-01-29

No results posted yet for this 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

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

Interventions

DRUG

AP301

Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g

DRUG

AP301 Low Dose

Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • Alebund Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-13
Primary Completion
2026-06-20
Completion
2027-01-10
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06933472 on ClinicalTrials.gov