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RecruitingPhase 4NCT06597201

Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.

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.

Sponsor

Chengdu Qingshan Likang Pharmaceutical Co., Ltd

Enrollment

400 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

End Stage Renal Disease (ESRD)

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special amino acid-based dialysis solution in people on peritoneal dialysis (a type of kidney failure treatment done at home through the abdomen) who are also malnourished, to see if it can improve their nutritional status. **You may be eligible if...** - You are between 18 and 75 years old - You have been on peritoneal dialysis for at least 3 months with a stable routine - You have mild malnutrition based on blood protein (albumin) levels - Your blood potassium and other lab values are within acceptable ranges **You may NOT be eligible if...** - You had peritonitis, another infection, or were hospitalized in the past 3 months - You may receive a kidney transplant during the study - Your dialysis is inadequate - You are severely anemic (hemoglobin below 80 g/L) - You have used amino acid dialysis solution in the past 6 months - You had a stroke, heart attack, or serious bleeding episode in the past 30 days - You have liver disease, HIV, active hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGamino 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).

DRUGglucose 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

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NCT06597201

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