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Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
Sponsor: Chengdu Qingshan Likang Pharmaceutical Co., Ltd
Summary
This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance.
Official title: Multicenter, Prospective, Open-label, Randomized, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2024-08-09
Completion Date
2025-06-29
Last Updated
2024-12-30
Healthy Volunteers
No
Conditions
Interventions
amino acid (15) peritoneal dialysis solution
Subjects were treated with 1 bag of amino acid (15) peritoneal dialysis solution (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
glucose peritoneal dialysis solution
Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.
Locations (21)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People&'s Hospital
Beijing, Beijing Municipality, China
Wuhan NO.1 Hospital
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Ganzhou People's Hospital
Ganzhou, China
Affiliated Hospital of Guangdong Medical University
Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The Affiliated Hospital of Southwest Medical University
Luzhou, China
Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)
Meishan, China
Jiangsu Province Hosipital
Nanjing, China
The Affiliated Hospital of Nanjing university Medical School
Nanjing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai, China
General Hospital of Northern Theater Command
Shenyang, China
The Central Hospital of Wuhan
Wuhan, China
Zhongshan Hospital Xiamen University
Xiamen, China
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, China
The Second People's Hospital of Yibin City
Yibin, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China