Tests amino acid peritoneal dialysis solution in malnourished dialysis patients
Compares an amino acid dialysis solution with glucose solution in malnourished kidney failure patients.
Plain-language title generated from the registry record
Registry title: Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Ganzhou, Guangdong, Guangzhou, Hefei, Luzhou, Meishan, Nanjing, Nanning, Shanghai, Shenyang, Wuhan, Xiamen, Xinxiang, Yibin, and Zhengzhou, ChinaSee the 21 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with end-stage kidney disease who have been on stable peritoneal dialysis (CAPD) for at least 3 months and have low blood albumin.
- Age
- 18 to 75 years (both included)
- Sex
- All sexes
- Disease stage
- End-stage kidney disease on stable CAPD peritoneal dialysis for at least 3 months, with serum albumin (ALB) from 25 to 40 g/L on two occasions one week apart
- Earlier treatment
- Peritoneal dialysis for at least 3 months; no amino acid (15) peritoneal dialysate in the 6 months before screening
- Biomarker or test result
- Blood potassium of 3.5 mmol/L or more; C-reactive protein no more than 2 times the upper limit of normal; carbon dioxide binding capacity above 18 mmol/L
Main reasons for not taking part
- Peritonitis, other infection or inflammatory disease with hospital stay in the past 3 months
- Possible kidney transplant during the study
- Inadequate dialysis (kt/v below 1.4) or hemoglobin below 80g/L
- Bleeding, heart or brain vessel events in the 30 days before screening
- Pregnancy or breastfeeding
This trial only enrols participants on dialysis. The registry sentence this rests on: Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months;
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06597201, who can take part
Where in China
- Peking University People&'s HospitalBeijing, ChinaTaking people
- The Third Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- The Second Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- Ganzhou People's HospitalGanzhou, ChinaTaking people
- Affiliated Hospital of Guangdong Medical UniversityGuangdong, ChinaTaking people
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
- The Affiliated Hospital of Southwest Medical UniversityLuzhou, ChinaTaking people
- Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)Meishan, ChinaTaking people
- Jiangsu Province HosipitalNanjing, ChinaTaking people
- The Affiliated Hospital of Nanjing university Medical SchoolNanjing, ChinaTaking people
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
- Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong UniversityShanghai, ChinaTaking people
- General Hospital of Northern Theater CommandShenyang, ChinaTaking people
- The Central Hospital of WuhanWuhan, ChinaTaking people
- Wuhan NO.1 HospitalWuhan, ChinaTaking people
- Zhongshan Hospital Xiamen UniversityXiamen, ChinaTaking people
- The First Affiliated Hospital of Xinxiang Medical CollegeXinxiang, ChinaTaking people
- The Second People's Hospital of Yibin CityYibin, ChinaTaking people
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chengdu Qingshan Likang Pharmaceutical Co., Ltd
- Trial code
- NCT06597201
- Record updated
- 30 December 2024
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: 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.
Exclusion: Within the past 3 months prior to the screening period, there has been a history of peritonitis, other infections, or inflammatory diseases, with hospitalization records; The possibility of receiving a kidney transplant during the study period; Patients who have used amino acid (15) peritoneal dialysate within 6 months prior to the screening period; Patients with bleeding events (active gastrointestinal hemorrhage, cerebral hemorrhage), cardiovascular and cerebrovascular events (cerebral infarction, myocardial infarction, etc., and NYHA grade ≥3 of cardiac function) within 30 days before screening period; Diabetic subjects with poor prior glycemic control, e.g., HbAlc > 8%; Suffers from a malignant tumor or has a life expectancy of \<6 months; Patients with hemoglobin less than 80g/L during the screening period; patients with contraindications to amino acid (15) peritoneal dialysis solutions: 1) hypersensitivity to any of the components of the product; 2) Serum urea level >38 mmol/l; 3) Presence of uremic symptoms such as marked loss of appetite, nausea and vomiting at the time of screening; 4) Various inborn abnormalities of amino acid metabolism; 5) hepatic insufficiency (active hepatitis); active hepatitis B or C, cirrhosis, active liver disease or positive seropositivity for human immunodeficiency virus (HIV) within 6 months prior to screening; 6) Uncorrectable mechanical defects that the investigator assesses as affecting efficacy or increasing the risk of infection; 7) History of loss of peritoneal function or impairment of peritoneal function due to extensive adhesions; Routine daily use of 4.25% glucose dialysis solution during the screening period; Patients with inadequate dialysis and screening period kt/v<1.4; In patients with active diarrhea during the screening period, as assessed by investigators, affecting nutrient absorption(Except for patients with chronic diarrhea, stool frequency < 3 times/day); Women during pregnancy or breastfeeding; Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.