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

Study acronym: RESPOND-2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 29, 2026 (before its estimated June 20, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Site details revised at 28 of 42 sitesv8
  2. Minor Study sites: 31 to 42
    • Eligibility criteria expanded, about 3 words
    v7
  3. Minor Study sites: 7 to 31v6
  4. Minor Site contacts updated at 1 of 7 sitesv5
  5. Minor Start date: Jun 6, 2025 to Jun 13, 2025
    • Site details revised at 7 of 7 sites
    • Collaborators expanded, about 1 word
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Site details revised at 2 of 7 sitesv3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 1, 2025 to Jun 6, 2025
    • Study sites: 0 to 7
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06933472
Lead Sponsor Alebund Pharmaceuticals
Collaborators: Fortrea
Conditions
(from sponsor)
Hyperphosphatemia, Chronic Kidney Disease, Receiving Dialysis, ESRD (End-Stage Renal Disease), Dialysis
Related terms Hyperphosphatemia, Renal Insufficiency, Chronic
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov