AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

PHASE3CompletedINTERVENTIONAL
Enrollment

474

Participants

Timeline

Start Date

June 12, 2023

Primary Completion Date

October 2, 2024

Study Completion Date

May 30, 2025

Conditions
ESRD (End Stage Renal Disease)Chronic Kidney Disease(CKD)HyperphosphatemiaHyperphosphatemia in Chronic Kidney DiseaseDialysisChronic Kidney Disease, Receiving Dialysis
Interventions
DRUG

AP301

Three times a day, administered orally with three meals at a daily dose level from 2.1g to 9.1g

DRUG

Sevelamer carbonate (Renvela®)

Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g

DRUG

AP301 Low Dose

Three times a day, administered orally with three meals at a daily dose level of 0.375g.

Trial Locations (50)

100029

Beijing Anzhen Hospital, Capital Medical University, Beijing

100034

Peking University First Hospital, Beijing

100035

Beijing Jishuitan Hospital, Beijing

100082

Peking University People's Hospital, Beijing

100191

Peking University Third Hospital, Beijing

102206

Peking University International Hospital, Beijing

102218

Beijing Tsinghua Changgung Hospital, Beijing

116011

The First Affiliated Hospital of Dalian Medical University, Dalian

116083

Dalian Municipal Central Hospital, Dalian

130021

Jilin Province People's Hospital, Jilin

130041

The Second Norman Bethune Hospital of Jilin University, Jilin

200040

Huashan Hospital Affiliated to Fudan University, Shanghai

200072

Shanghai Tenth People's Hospital, Shanghai

200082

Shanghai General Hospital, Shanghai

200092

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

200127

Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai

200233

Shanghai Sixth People's Hospital, Shanghai

210009

Zhongda Hospital Southeast University, Nanjing

210011

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

210029

Jiangsu Province Hosipital, Nanjing

213004

Changzhou NO.2 People's Hospital, Changzhou

214023

Wuxi People's Hospital, Wuxi

221009

Xuzhou Central Hospital, Xuzhou

225003

Northern Jiangsu People's Hospital, Yangzhou

226007

Affiliated Hospital of Nantong University, Nantong

266003

The Affiliated Hospital of Qingdao University, Qingdao

300121

Tianjin People's Hospital, Tianjin

310009

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

330006

Jiangxi Provincial People's Hospital, Nanchang

The First Affiliated Hospital of Nanchang University, Nanchang

361003

The First Affiliated Hospital of Xiamen University, Xiamen

361004

Zhongshan Hospital Xiamen University, Xiamen

410011

The Second Xiangya Hospital of Central South University, Changsha

410031

The Third Xiangya Hospital of Central South University, Changsha

430030

Hospital of Universal Love, Wuhan

430060

Renmin Hospital of Wuhan University, Wuhan

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

510080

Guangdong Provincial People's Hospital, Guangzhou

523058

Dongguan People's Hospital, Guangzhou

530016

The First People's Hospital of Nanning, Nanning

541001

Affiliated Hospital of Guilin Medical University, Guilin

610044

West China Hospital of Sichuan University, Chengdu

610072

Sichuan Provincial People's Hospital, Chengdu

730030

Lanzhou University Second Hospital, Lanzhou

Unknown

Guangzhou First People's Hospital, Guangzhou

050011

The Fourth Hospital of Hebei Medical University, Shijiazhuang

050052

The Third Hospital of Hebei Medical University, Shijiazhuang

054002

The Second Affiliated Hospital Of Xingtai Medical College, Xingtai

030001

Second Hospital of Shanxi Medical University, Taiyuan

030032

Shanxi Bethune Hospital, Taiyuan

Sponsors
All Listed Sponsors
lead

Alebund Pharmaceuticals

INDUSTRY