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Clinical Trial Details

Trial ID: L0839
Source ID: NCT06597201
Associated Drug: Amino Acid (15) Peritoneal Dialysis Solution
Title: Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: End Stage Renal Disease (ESRD)
Interventions: DRUG: amino acid (15) peritoneal dialysis solution|DRUG: glucose peritoneal dialysis solution
Outcome Measures: Primary: ALB, To compare the difference in change from baseline in serum albumin (ALB) after 90 days of treatment of CAPD patients with amino acid (15) peritoneal dialysis solution versus conventional glucose peritoneal dialysis solution (lactate)., After 90 days of treatment | Secondary: serum transferrin, To compare the changes of serum transferrin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline., After 30, 60, and 90 days of treatment|arm muscle circumference (AMC), omparison of standardized upper arm muscle circumference (AMC) changes from baseline after fasting peritoneal dialysis fluid emptying between amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) in CAPD patients treated for 90 days., After 90 days of treatment|standardized protein nitrogen occurrence rate (nPNA), To compare the change of standardized protein nitrogen occurrence rate (nPNA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline., After 90 days of treatment|subjective comprehensive nutritional assessment (SGA), To compare the change of subjective comprehensive nutritional assessment (SGA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline., After 90 days of treatment|middle arm muscle circumference (MAMC), To compare the change of middle arm muscle circumference (MAMC) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline., After 90 days of treatment|serum prealbumin, To compare the changes of serum prealbumin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline., After 30, 60, and 90 days of treatment|serum albumin, To compare the changes of serum albumin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline., After 30, 60, and 90 days of treatment|body mass index (BMI), To compare the change of standardized protein nitrogen occurrence rate (nPNA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline., After 90 days of treatment
Sponsor/Collaborators: Sponsor: Chengdu Qingshan Likang Pharmaceutical Co., Ltd
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 400
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-09
Completion Date: 2025-06-29
Results First Posted:
Last Update Posted: 2024-12-30
Locations: The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, 230022, China|Peking University People&'s Hospital, Beijing, Beijing, 100044, China|Wuhan NO.1 Hospital, Wuhan, Hubei, China|The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410000, 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|West China Hospital, Sichuan University, Chengdu, 四川, 610000, China
URL: https://clinicaltrials.gov/show/NCT06597201