Chronic Kidney Disease, Receiving Dialysis, Dialysis, ESRD (End-Stage Renal Disease), Hyperphosphatemia
Conditions
Keywords
Hyperphosphatemia, AP301, Dialysis, ESKD
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.
Interventions
DRUGAP301
Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
DRUGAP301 Low Dose
Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g
Sponsors
Alebund Pharmaceuticals
Fortrea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 * Patients who receive phosphate-lowering drugs 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China, United States
Contacts
CONTACTWeifeng Zhang, M.D.
CONTACTBobby Zang
Outcome results
None listed