AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

Prior treatment

• History or plan of kidney transplantation
• History or plan of parathyroid intervention 6 months before signing the ICF
• History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF

Other illness

• Presence of clinically significant gastrointestinal (GI) disorder
• Known allergic to any ingredient of AP301 or Sevelamer Carbonate, or known history of severe allergies leading to emergency medical care

Lab values

• Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or \> 2.75 mmol/L (11 mg/dL) at screening
• Serum intact parathyroid hormone \> 110 pmol/L (1000 pg/mL) at screening

Other

• Female who are breastfeeding

• 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
• For patients who receive phosphate binders and their serum phosphate level is:
  • Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
  • After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)
• For patients who do not receive phosphate binders over 2 weeks and their serum phosphate level is:
  • Screening: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)