A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
RESPOND-2
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
1 other identifier
interventional
264
2 countries
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2025
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2025
CompletedFirst Posted
Study publicly available on registry
April 18, 2025
CompletedStudy Start
First participant enrolled
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 10, 2027
January 29, 2026
June 1, 2025
1 year
March 19, 2025
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
From Baseline to the end of Week 8
Secondary Outcomes (5)
Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups
From the beginning of Week 33 to the end of Week 35
Change in serum phosphate concentrations over time throughout the study
From Baseline to the end of Week 35
Change in serum calcium (Ca) and intact parathyroid hormone levels over time
From Baseline to the end of Week 35
Number of adverse events
From Baseline to Follow-up (Up to 37 weeks)
Change in QT intervals measured by 12-lead electrocardiagram test over time
From Baseline to the end of Week 35
Other Outcomes (2)
Change in the health-related quality of life questionnaires of EQ-5D-5L in Chinese patients only
From Baseline to Week 33
Change in the health-related quality of life questionnaires of KDQoL-36 in Chinese only
From Baseline to Week 33
Study Arms (2)
AP301
EXPERIMENTALA blood phosphate-lowering medication containing iron
AP301 Low Dose
EXPERIMENTALA blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective
Interventions
Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alebund Pharmaceuticalslead
- Fortreacollaborator
Study Sites (42)
Renal Consultants Medical Group
Granada Hills, California, 91344, United States
North America Research Institute - San Dimas
San Dimas, California, 91773, United States
North America Research Institute - San Dimas
San Dimas, California, 91773, United States
Rocky Mountain Kidney Care - Lone Tree
Lone Tree, Colorado, 80124, United States
PACT Kidney Care - Orange
Orange, Connecticut, 06477, United States
US Renal Care - Fort Myers South
Fort Myers, Florida, 33912, United States
Nephrology & Hypertension Specialists
Dalton, Georgia, 30720, United States
Renal Associates Of Baton Rouge, LLC
Baton Rouge, Louisiana, 70808, United States
Nephrology Associates, P.C. - Columbus
Columbus, Mississippi, 38801, United States
Nephrology & Hypertension Associates Ltd - Tupelo
Tupelo, Mississippi, 38801, United States
High Desert Nephrology Association - US Renal Care
Gallup, New Mexico, 87301, United States
US Renal Care - West Cheektowaga
Cheektowaga, New York, 14215, United States
NY Kidney & Hypertension Medicine
Ridgewood, New York, 11385, United States
US Renal Care - Alexis
Toledo, Ohio, 43613, United States
Dallas Renal Group - Dallas
Dallas, Texas, 75237, United States
US Renal Care - Bluebonnet
Fort Worth, Texas, 76110, United States
Gamma Medical Research
McAllen, Texas, 78503, United States
US Renal Care - South San Antonio
San Antonio, Texas, 78211, United States
US Renal Care - Hill Country
San Antonio, Texas, 78251, United States
Peking University First Hospital
Beijing, Beijing Municipality, 100035, China
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218, China
Peking University International Hospital
Beijing, Beijing Municipality, 102218, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Zhengzhou University-First Affiliated Hospital
Zhengzhou, Henan, 450003, China
Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union Hospital
Wuhan, Hubei, 430022, China
Wuhan University People's Hospital
Wuhan, Hubei, 430060, China
Central South University-The Third Xiangya Hospital
Changsha, Hunan, 410013, China
Southeast University-Zhongda Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Nanjing, Jiangsu, 210029, China
Nantong University-Affiliated Hospital
Nantong, Jiangsu, 226001, China
Nanjing Medical University-Wuxi People's Hospital (Wuxi No.1 People's Hospital)
Wuxi, Jiangsu, 214023, China
Subei People's Hospital
Yangzhou, Jiangsu, 225002, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Qingdao University-The Affiliated Hospital
Qingdao, Shandong, 266000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji Hospital
Shanghai, Shanghai Municipality, 200000, China
Fudan University-Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Fudan University-Huashan Hospital
Shanghai, Shanghai Municipality, 200040, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200080, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200336, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2025
First Posted
April 18, 2025
Study Start
June 13, 2025
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
January 10, 2027
Last Updated
January 29, 2026
Record last verified: 2025-06