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.
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 18 to 75 years of age (including 18 and 75 years of age), regardless of sex;
• Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months;
• 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart);
• Blood potassium ≥ 3.5 mmol/L
• C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN);
• Carbon dioxide binding capacity \>18 mmol/L;
• Subjects voluntarily sign an informed consent form in writing prior to the commencement of any procedures related to the study, fully understand the purpose and significance of the trial, and are willing to comply with the trial protocol.
Locations
Other Locations
China
Peking University People&'s Hospital
RECRUITING
Beijing
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital, Sichuan University
RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Ganzhou People's Hospital
RECRUITING
Ganzhou
Affiliated Hospital of Guangdong Medical University
RECRUITING
Guangdong
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The Affiliated Hospital of Southwest Medical University
RECRUITING
Luzhou
Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)
RECRUITING
Meishan
Jiangsu Province Hosipital
RECRUITING
Nanjing
The Affiliated Hospital of Nanjing university Medical School
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
RECRUITING
Shanghai
General Hospital of Northern Theater Command
RECRUITING
Shenyang
The Central Hospital of Wuhan
RECRUITING
Wuhan
Wuhan NO.1 Hospital
RECRUITING
Wuhan
Zhongshan Hospital Xiamen University
RECRUITING
Xiamen
The First Affiliated Hospital of Xinxiang Medical College
RECRUITING
Xinxiang
The Second People's Hospital of Yibin City
RECRUITING
Yibin
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Qian Deng
dq0416@qq.com
86 136 9940 1416
Time Frame
Start Date:2024-08-09
Estimated Completion Date:2025-06-29
Participants
Target number of participants:400
Treatments
Experimental: experimental group
Subjects were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
Active_comparator: control group
Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.