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

Phase 3

Not yet recruiting

• Conditions: Hyperphosphatemia; Chronic Kidney Disease, Receiving Dialysis; ESRD (End-Stage Renal Disease); Dialysis
• Interventions: Drug: AP301; Drug: AP301 Low Dose

• Registration Number: NCT06933472
• Lead Sponsor: Alebund Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-19
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-05-01
• Primary Completion: 2026-06-20
• Study Completion: 2027-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Provision of signed and dated ICF

• Adult 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 binders 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AP301	AP301	A blood phosphate-lowering mediation containing iron
AP301 Low Dose	AP301 Low Dose	A blood phosphate-lowering mediation containing iron, but with a low dose considered as ineffective

Primary Outcome Measures

Name	Time	Method
Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups	From Baseline to the end of Week 8	The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.

Secondary Outcome Measures

Name	Time	Method
Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups	From the beginning of Week 33 to the end of Week 35	The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 maintenance dose and the group receiving AP301 low dose.
Change in serum phosphate concentrations over time throughout the study	From Baseline to the end of Week 35
Change in serum calcium (Ca) and intact parathyroid hormone levels over time	From Baseline to the end of Week 35	The amount of calcium and intact parathyroid hormone (iPTH) in the blood will be measured with standard laboratory tests.
Number of adverse events	From Baseline to Follow-up (Up to 37 weeks)
Change in QT intervals measured by 12-lead electrocardiagram test over time	From Baseline to the end of Week 35	The duration of QT intervals will be measured with a standard 12-lead electrocardiagram test.