A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Recruiting · NCT06933472 · Interventional (participants receive a specific treatment) · Lead sponsor: Alebund Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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:
- 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)
- 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
Where it is running
42 locations listed across 11 US states.
- 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