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AP301, an iron-based phosphate binder, for people on dialysis with high blood phosphate

A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

Phase 3 Interventional Alebund Pharmaceuticals · NCT06933472

This study will test whether the iron-based drug AP301 can lower high blood phosphate in people with end-stage kidney disease who are on maintenance dialysis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment264 (estimated)
Ages12 Years and up
SexAll
SponsorAlebund Pharmaceuticals Industry-sponsored
Locations42 sites (Granada Hills, California and 41 other locations)
Trial IDNCT06933472 on ClinicalTrials.gov

What this trial studies

After stopping other phosphate-lowering drugs, eligible dialysis patients are randomized to receive AP301 or a low-dose look-alike comparator three times daily for an initial 8-week double-blind period. Following that, participants receive open-label AP301 for 24 weeks and then enter a short final treatment period, with regular blood tests and safety monitoring throughout. Key outcomes include change in serum phosphate, serum calcium, calcium-phosphate product, intact parathyroid hormone, adverse events, and quality of life measures in the Chinese cohort. The trial enrolls patients aged 12 and older who have been on dialysis for at least three months and meet predefined phosphate and dialysis adequacy thresholds.

Who should consider this trial

Good fit: Ideal candidates are people aged 12 or older who have been on maintenance hemodialysis or peritoneal dialysis for at least three months, meet the study's phosphate ranges after washout, and have adequate dialysis adequacy (spKt/V ≥1.2 for HD or total Kt/V ≥1.7/week for PD).

Not a fit: Patients with recent gastrointestinal surgery, clinically significant GI disorders, very low or very high serum calcium, very high intact parathyroid hormone, or plans for kidney transplant or parathyroid intervention are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, AP301 could provide another effective option to lower blood phosphate and reduce complications of mineral imbalance in people on dialysis.

How similar studies have performed: Other iron-based phosphate binders (for example, ferric citrate and sucroferric oxyhydroxide) have shown effectiveness at lowering serum phosphate, so the general approach has precedent though AP301 itself is a novel formulation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Provision of signed and dated ICF
* Age ≥ 12 years when signing the ICF
* Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
* For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
* Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:

  1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
  2. After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)

Key Exclusion Criteria:

* History or plan of kidney transplantation
* History or plan of parathyroid intervention 6 months before signing the ICF
* Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or \> 2.75 mmol/L (11 mg/dL) at screening
* Serum intact parathyroid hormone \> 127 pmol/L (1200 pg/mL) at screening
* Presence of clinically significant gastrointestinal (GI) disorder
* History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
* Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
* Female who are breastfeeding

Where this trial is running

Granada Hills, California and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HyperphosphatemiaChronic Kidney Disease, Receiving DialysisESRDDialysisAP301ESKD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.