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
Parallel
AP301
DrugThree times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
AP301 Low Dose
DrugThree times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g
Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
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.
Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups
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
Change in serum calcium (Ca) and intact parathyroid hormone levels over time
The amount of calcium and intact parathyroid hormone (iPTH) in the blood will be measured with standard laboratory tests.
Number of adverse events
Change in the health-related quality of life questionnaires of EQ-5D-5L in Chinese patients only
The change in the scores of the questionnaire EuroQol 5-Dimension 5-Level (EQ-5D-5L), including the health state index score (the higher, the better quality of life) and the visual anaglog scale (ranging from 0 to 100; the higher, the better quality of life).
Change in the health-related quality of life questionnaires of KDQoL-36 in Chinese only
The change in the scores of the questionnaire Kidney Disease Quality of Life 36-item short form (KDQoL-36). The score ranges from 0 to 100 for five domains, with higher scores indicating better quality of life.
Click on the lead sponsor to view all of their trials.
Alebund Pharmaceuticals
Lead sponsor
Fortrea
Collaborator
