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A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Sponsor: Alebund Pharmaceuticals
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.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2025-06-13
Completion Date
2027-01-10
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
AP301
Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
AP301 Low Dose
Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g
Locations (42)
Renal Consultants Medical Group
Granada Hills, California, United States
North America Research Institute - San Dimas
San Dimas, California, United States
North America Research Institute - San Dimas
San Dimas, California, United States
Rocky Mountain Kidney Care - Lone Tree
Lone Tree, Colorado, United States
PACT Kidney Care - Orange
Orange, Connecticut, United States
US Renal Care - Fort Myers South
Fort Myers, Florida, United States
Nephrology & Hypertension Specialists
Dalton, Georgia, United States
Renal Associates Of Baton Rouge, LLC
Baton Rouge, Louisiana, United States
Nephrology Associates, P.C. - Columbus
Columbus, Mississippi, United States
Nephrology & Hypertension Associates Ltd - Tupelo
Tupelo, Mississippi, United States
High Desert Nephrology Association - US Renal Care
Gallup, New Mexico, United States
US Renal Care - West Cheektowaga
Cheektowaga, New York, United States
NY Kidney & Hypertension Medicine
Ridgewood, New York, United States
US Renal Care - Alexis
Toledo, Ohio, United States
Dallas Renal Group - Dallas
Dallas, Texas, United States
US Renal Care - Bluebonnet
Fort Worth, Texas, United States
Gamma Medical Research
McAllen, Texas, United States
US Renal Care - South San Antonio
San Antonio, Texas, United States
US Renal Care - Hill Country
San Antonio, Texas, United States
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhengzhou University-First Affiliated Hospital
Zhengzhou, Henan, China
Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union Hospital
Wuhan, Hubei, China
Wuhan University People's Hospital
Wuhan, Hubei, China
Central South University-The Third Xiangya Hospital
Changsha, Hunan, China
Southeast University-Zhongda Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, China
Nantong University-Affiliated Hospital
Nantong, Jiangsu, China
Nanjing Medical University-Wuxi People's Hospital (Wuxi No.1 People's Hospital)
Wuxi, Jiangsu, China
Subei People's Hospital
Yangzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
Qingdao University-The Affiliated Hospital
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji Hospital
Shanghai, Shanghai Municipality, China
Fudan University-Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Fudan University-Huashan Hospital
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China