Actively Recruiting
A Randomized, Double-Blind, Multi-Regional Phase 3 Study Evaluating AP301 for Serum Phosphorus Control in Dialysis Patients with Hyperphosphatemia
Led by Alebund Pharmaceuticals · Updated on 2026-01-29
264
Participants Needed
42
Research Sites
29 weeks
Total Duration
On this page
Sponsors
A
Alebund Pharmaceuticals
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating AP301, a novel iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have elevated blood phosphate levels. This phase 3, randomized, double-blind study aims to determine whether AP301 lowers blood phosphate and how it affects serum calcium, calcium times phosphate, and intact parathyroid hormone levels. The trial also assesses any discomfort or medical problems during treatment and its impact on quality of life in Chinese patients. Participants will first stop all phosphate-lowering medications. They will then take either AP301 or a low-dose comparator (considered ineffective) three times daily for 8 weeks. Following this, all participants receive AP301 three times daily for 24 weeks, with dose adjustments based on blood phosphate levels and physician judgment. Finally, participants will take either AP301 or the comparator three times daily for 3 weeks. Additional treatments may be given if blood phosphate levels become too high or low. During the study, participants will undergo regular assessments including blood tests to monitor serum phosphate, calcium, and parathyroid hormone levels. Electrocardiogram tests will measure changes in QT intervals. Safety is monitored by tracking adverse events throughout the trial, which lasts up to 37 weeks. The primary outcome is the change in serum phosphate concentration from baseline to the end of week 8, with ongoing evaluations over the entire study period.
CONDITIONS
Brief 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 signing
- Receiving dialysis for at least 3 months before and during the study
- For hemodialysis patients, spKt/V ≥ 1.2; for peritoneal dialysis patients, total Kt/V ≥ 1.7/week
- Serum phosphate levels within 1.13 to 2.58 mmol/L (3.5 to 8.0 mg/dL) at screening
- After washout, serum phosphate levels between 1.94 and 3.23 mmol/L (6.0 to 10.0 mg/dL)
You will not qualify if you...
- History or plans for kidney transplantation
- History or plans for parathyroid intervention within 6 months before signing consent
- Serum calcium below 1.9 mmol/L (7.6 mg/dL) or above 2.75 mmol/L (11 mg/dL) at screening
- Serum intact parathyroid hormone above 127 pmol/L (1200 pg/mL) at screening
- Presence of significant gastrointestinal disorders
- History of gastrectomy, duodenectomy, or gastrointestinal surgery within 3 months before signing consent
- Known allergy to any AP301 ingredient or severe allergy history requiring emergency care
- Females who are breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants take the study medication AP301 or a low dose version orally three times a day with meals to control serum phosphate levels.
Regular visits during treatment period
Duration - Up to 29 weeks after treatment
Participants are monitored for safety and changes in serum phosphate and other blood levels after treatment ends.
Visits up to Week 37
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.
B
Bobby Zang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here