Actively Recruiting
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Led by Alebund Pharmaceuticals · Updated on 2026-01-29
264
Participants Needed
42
Research Sites
82 weeks
Total Duration
On this page
Sponsors
A
Alebund Pharmaceuticals
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age 12 years or older at consent
- On dialysis treatment for at least 3 months before and during the study
- For hemodialysis patients, spKt/V of 1.2 or higher; for peritoneal dialysis patients, total Kt/V of 1.7/week or higher
- Serum phosphate level between 3.5 and 8.0 mg/dL at screening
- After stopping phosphate-lowering drugs, serum phosphate level between 6.0 and 10.0 mg/dL
You will not qualify if you...
- History or plan for kidney transplantation
- History or plan for parathyroid intervention within 6 months before consent
- Serum calcium below 7.6 mg/dL or above 11 mg/dL at screening
- Serum intact parathyroid hormone above 1200 pg/mL at screening
- Clinically significant gastrointestinal disorder
- History of stomach or duodenal surgery within 3 months before consent
- Known allergy to any ingredient of AP301 or history of severe allergies requiring emergency care
- Females who are breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Renal Consultants Medical Group
Granada Hills, California, United States, 91344
Actively Recruiting
2
North America Research Institute - San Dimas
San Dimas, California, United States, 91773
Actively Recruiting
3
North America Research Institute - San Dimas
San Dimas, California, United States, 91773
Actively Recruiting
4
Rocky Mountain Kidney Care - Lone Tree
Lone Tree, Colorado, United States, 80124
Actively Recruiting
5
PACT Kidney Care - Orange
Orange, Connecticut, United States, 06477
Actively Recruiting
6
US Renal Care - Fort Myers South
Fort Myers, Florida, United States, 33912
Actively Recruiting
7
Nephrology & Hypertension Specialists
Dalton, Georgia, United States, 30720
Actively Recruiting
8
Renal Associates Of Baton Rouge, LLC
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
9
Nephrology Associates, P.C. - Columbus
Columbus, Mississippi, United States, 38801
Actively Recruiting
10
Nephrology & Hypertension Associates Ltd - Tupelo
Tupelo, Mississippi, United States, 38801
Actively Recruiting
11
High Desert Nephrology Association - US Renal Care
Gallup, New Mexico, United States, 87301
Actively Recruiting
12
US Renal Care - West Cheektowaga
Cheektowaga, New York, United States, 14215
Actively Recruiting
13
NY Kidney & Hypertension Medicine
Ridgewood, New York, United States, 11385
Actively Recruiting
14
US Renal Care - Alexis
Toledo, Ohio, United States, 43613
Actively Recruiting
15
Dallas Renal Group - Dallas
Dallas, Texas, United States, 75237
Actively Recruiting
16
US Renal Care - Bluebonnet
Fort Worth, Texas, United States, 76110
Actively Recruiting
17
Gamma Medical Research
McAllen, Texas, United States, 78503
Actively Recruiting
18
US Renal Care - South San Antonio
San Antonio, Texas, United States, 78211
Actively Recruiting
19
US Renal Care - Hill Country
San Antonio, Texas, United States, 78251
Actively Recruiting
20
Peking University First Hospital
Beijing, Beijing Municipality, China, 100035
Actively Recruiting
21
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
22
Peking University International Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
23
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
24
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
25
Zhengzhou University-First Affiliated Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
26
Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
27
Wuhan University People's Hospital
Wuhan, Hubei, China, 430060
Actively Recruiting
28
Central South University-The Third Xiangya Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
29
Southeast University-Zhongda Hospital
Nanjing, Jiangsu, China, 210009
Actively Recruiting
30
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, China, 210029
Actively Recruiting
31
Nantong University-Affiliated Hospital
Nantong, Jiangsu, China, 226001
Actively Recruiting
32
Nanjing Medical University-Wuxi People's Hospital (Wuxi No.1 People's Hospital)
Wuxi, Jiangsu, China, 214023
Actively Recruiting
33
Subei People's Hospital
Yangzhou, Jiangsu, China, 225002
Actively Recruiting
34
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Actively Recruiting
35
Qingdao University-The Affiliated Hospital
Qingdao, Shandong, China, 266000
Actively Recruiting
36
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264099
Actively Recruiting
37
Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
38
Fudan University-Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
39
Fudan University-Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
40
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200080
Not Yet Recruiting
41
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China, 200336
Actively Recruiting
42
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
Research Team
W
Weifeng Zhang, M.D.
CONTACT
B
Bobby Zang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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