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.
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
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
Alebund Pharmaceuticals
Lead sponsor
Fortrea
Collaborator