Tests AP301 to lower blood phosphate in people on dialysis
Tests AP301 against a look-alike pill in people on dialysis with high phosphate.
Plain-language title generated from the registry record
Registry title: A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Key facts
- Where
- Beijing, Changsha, Chengdu, Nanchang, Nanjing, Nantong, Qingdao, Shanghai, Wuhan, Wuxi, Xiamen, Yangzhou, Yantai, and Zhengzhou, ChinaSee the 23 sites
- Phase
- Phase 3
Where in China
- Beijing Tsinghua Chang Gung HospitalBeijing, ChinaTaking people
- Peking University First HospitalBeijing, ChinaTaking people
- Peking University International HospitalBeijing, ChinaTaking people
- Central South University-The Third Xiangya HospitalChangsha, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- Jiangxi Provincial People's HospitalNanchang, ChinaTaking people
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)Nanjing, ChinaTaking people
- Southeast University Zhongda HospitalNanjing, ChinaTaking people
- Nantong University Affiliated HospitalNantong, ChinaTaking people
- Qingdao University-The Affiliated HospitalQingdao, ChinaTaking people
- Children's Hospital Of Fudan UniversityShanghai, ChinaNot yet recruiting
- Fudan University Huashan HospitalShanghai, ChinaTaking people
- Fudan University Zhongshan HospitalShanghai, ChinaTaking people
- Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji HospitalShanghai, ChinaTaking people
- Shanghai Tongren HospitalShanghai, ChinaTaking people
- Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union HospitalWuhan, ChinaTaking people
- Wuhan University People's HospitalWuhan, ChinaTaking people
- Nanjing Medical University-Wuxi People's Hospital (Wuxi No.1 People's Hospital)Wuxi, ChinaTaking people
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaTaking people
- Subei People's HospitalYangzhou, ChinaTaking people
- Yantai Yuhuangding HospitalYantai, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaTaking people
- Zhengzhou University - First Affiliated HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alebund Pharmaceuticals
- Trial code
- NCT06933472
- Record updated
- 29 January 2026
- Original description
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:Read full original descriptionShow less
A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia
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.
Inclusion: 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:; 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).
Exclusion: 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; Presence of clinically significant gastrointestinal (GI) disorder; Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care; 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; Female who are breastfeeding.