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

Launched by ALEBUND PHARMACEUTICALS · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AP301 to see if it can help lower high phosphate levels in patients who are on dialysis due to chronic kidney disease or end-stage renal disease. High phosphate levels can cause health problems, and this trial aims to find out if AP301 is effective in reducing these levels, improving calcium and parathyroid hormone levels, and enhancing patients' quality of life, particularly in Chinese patients. Participants will be compared to a look-alike treatment that doesn’t have the active ingredient to see if AP301 really makes a difference.

To be eligible for the trial, participants must be adults who have been on dialysis for at least three months and have specific phosphate levels. They will need to stop any other phosphate-lowering medications before starting the trial. During the study, participants will take AP301 or the comparison treatment three times a day for a total of about 32 weeks, with adjustments made based on their phosphate levels. This trial is not yet recruiting participants, but it aims to provide important insights into managing high phosphate levels in patients undergoing dialysis.

Gender

ALL

Eligibility criteria

• Key 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