New pill could help dialysis patients control dangerous phosphorus levels

NCT ID NCT07030595

Disease control Sponsor: Alebund Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested a new drug called AP301 in 474 Chinese adults on dialysis who had high phosphorus levels. Participants took AP301, a low dose of AP301, or the standard drug sevelamer carbonate with meals. The main goal was to see how well AP301 lowers phosphorus compared to the other groups. If it works, AP301 could become another option for managing phosphorus in kidney disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AP301 (a phosphate binder taken orally with meals)
What this could lead to: If successful, AP301 could offer a new treatment option to help dialysis patients control high phosphorus levels, potentially improving bone and heart health.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. AP301 may not be more effective or safer than existing binders, and individual responses vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

474 people

The number who actually took part.

Started

Jun 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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: 1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL) 2. 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: 1. Screening: 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 \> 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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure hyperphosphatemia wild type ABeta2M amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease (CKD) Chronic kidney disease, receiving dialysis Dialysis ESRD (end-stage renal disease) Hyperphosphatemia Hyperphosphatemia in chronic kidney disease

Contacts and locations

Locations

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541001, China
Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226007, China
Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China
Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China
Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China
Changzhou NO.2 People's Hospital

Changzhou, Jiangsu, 213004, China
Dalian Municipal Central Hospital

Dalian, Liaoning, 116083, China
Dongguan People's Hospital

Guangzhou, Guangdong, 523058, China
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China
Guangzhou First People's Hospital

Guangzhou, Guangdong, China
Hospital of Universal Love

Wuhan, Hubei, 430030, China
Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China
Jiangsu Province Hosipital

Nanjing, Jiangsu, 210029, China
Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China
Jilin Province People's Hospital

Jilin City, Changchun, 130021, China
Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China
Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225003, China
Peking University First Hospital

Beijing, Beijing Municipality, 100034, China
Peking University International Hospital

Beijing, Beijing Municipality, 102206, China
Peking University People's Hospital

Beijing, Beijing Municipality, 100082, China
Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China
Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China
Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China
Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China
Shanghai General Hospital

Shanghai, Shanghai Municipality, 200082, China
Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China
Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China
Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China
Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China
The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China
The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China
The First People's Hospital of Nanning

Nanning, Guangxi, 530016, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China
The Second Affiliated Hospital Of Xingtai Medical College

Xingtai, Hebei, 054002, China
The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China
The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China
The Second Norman Bethune Hospital of Jilin University

Jilin City, Changchun, 130041, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050052, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410031, China
Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300121, China
West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China
Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China
Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China
Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China
Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

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