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RECRUITING
NCT06597201
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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