AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia
RESPOND-1
A Randomized, Open-Label, Multi-Center, 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
474
1 country
50
Brief Summary
This Phase 3 clinical trial is the pivotal study of AP301 aiming to evaluate the efficacy and safety of AP301 for controlling serum phosphorus in chronic kidney disease receiving hemodialysis and peritoneal dialysis in Chinese patients with hyperphosphatemia.
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 2023
50 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
Study Start
First participant enrolled
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedFirst Submitted
Initial submission to the registry
June 5, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedNovember 17, 2025
June 1, 2025
1.3 years
June 5, 2025
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in serum phosphorus levels between AP301 and AP301 low dose groups in hyperphosphatemic patients
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
From the end of Week 24 to the end of Week 27
Change in serum phosphorus levels between AP301 and sevelamer carbonate groups in hyperphosphatemic patients
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving sevelamer carbonate.
From Baseline to the end of Week 12
Secondary Outcomes (11)
The achievement rate of serum phosphorus in the target range 1.13-1.78 mmol/L (3.5-5.5 mg/dL) (both inclusive).
From Baseline to the end of Week 52.
Changes in serum calcium
From Baseline to the end of Week 52
Changes in serum calcium times phosphorus product
From Baseline to the end of Week 52
Changes in intact parathyroid hormone
From Baseline to the end of Week 52
Changes in serum bone-specific alkaline phosphatase
From Baseline to the end of Week 52
- +6 more secondary outcomes
Other Outcomes (2)
Changes in average serum phosphorus levels
From the end of Week 48 to the end of Week 52
Number of adverse events
From the end of Week 48 to the end of Week 52
Study Arms (3)
AP301
EXPERIMENTALA blood phosphate-lowering medication containing iron
Sevelamer Carbonate
ACTIVE COMPARATORA marketed blood phosphate-lowering medication
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 2.1g to 9.1g
Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g
Three times a day, administered orally with three meals at a daily dose level of 0.375g.
Eligibility Criteria
You may qualify if:
- Provision of signed and dated ICF
- Adult 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
- For patients who receive phosphate binders 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)
- For patients who do not receive phosphate binders over 2 weeks and their serum phosphate level is:
- Screening: 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 \> 110 pmol/L (1000 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 Sevelamer Carbonate, or known history of severe allergies leading to emergency medical care
- Female who are breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, 100035, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100082, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Peking University International Hospital
Beijing, Beijing Municipality, 102206, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Jilin Province People's Hospital
Jilin, Changchun, 130021, China
The Second Norman Bethune Hospital of Jilin University
Jilin, Changchun, 130041, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Dongguan People's Hospital
Guangzhou, Guangdong, 523058, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
The First People's Hospital of Nanning
Nanning, Guangxi, 530016, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050052, China
The Second Affiliated Hospital Of Xingtai Medical College
Xingtai, Hebei, 054002, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hospital of Universal Love
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410031, China
Changzhou NO.2 People's Hospital
Changzhou, Jiangsu, 213004, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Jiangsu Province Hosipital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226007, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225003, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011, China
Dalian Municipal Central Hospital
Dalian, Liaoning, 116083, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200082, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2025
First Posted
June 22, 2025
Study Start
June 12, 2023
Primary Completion
October 2, 2024
Study Completion
May 30, 2025
Last Updated
November 17, 2025
Record last verified: 2025-06