Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
NCT ID: NCT06597201
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
400 participants
INTERVENTIONAL
2024-08-09
2025-06-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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).
control group
Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
2. Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months;
3. 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart);
4. Blood potassium ≥ 3.5 mmol/L
5. C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN);
6. Carbon dioxide binding capacity \>18 mmol/L;
7. 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 Criteria
2. The possibility of receiving a kidney transplant during the study period;
3. Patients with inadequate dialysis and screening period kt/v\<1.4;
4. Patients with hemoglobin less than 80g/L during the screening period;
5. Patients who have used amino acid (15) peritoneal dialysate within 6 months prior to the screening period.
6. 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.
7. 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);
8. 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;
9. Suffers from a malignant tumor or has a life expectancy of \<6 months;
10. Routine daily use of 4.25% glucose dialysis solution during the screening period;
11. Diabetic subjects with poor prior glycemic control, e.g., HbAlc \> 8%;
12. Women during pregnancy or breastfeeding;
13. Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.
18 Years
75 Years
ALL
No
Sponsors
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Chengdu Qingshan Likang Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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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&#39;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&amp;#39;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
Countries
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Central Contacts
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Facility Contacts
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Yonggui Wu
Role: primary
Li Zuo
Role: primary
Fei Xiong
Role: primary
Hao Zhang
Role: primary
Ping Fu
Role: primary
Xiaohui Liao
Role: primary
Dehui Liu
Role: primary
Cuiwei Yao
Role: primary
Wei Chen
Role: primary
Santao Ou
Role: primary
Zaizhi Zhu
Role: primary
Huijuan Mao
Role: primary
Chunming Jiang
Role: primary
Zhenhua Yang
Role: primary
Niansong Wang
Role: primary
Yanning Zhang
Role: primary
Wenli Chen
Role: primary
Hancheng Guo
Role: primary
Xiangdong Liu
Role: primary
Lei Zhu
Role: primary
Zhanzheng Zhao
Role: primary
References
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My Thuc LT, Dung NQ, Ha VN, Tam ND, Hang Nga NT. Actual diet and nutritional deficiencies status in children on peritoneal dialysis at the Vietnam National Hospital of Pediatrics. Saudi J Kidney Dis Transpl. 2019 Jul-Aug;30(4):924-931. doi: 10.4103/1319-2442.265470.
Kopple JD, Bernard D, Messana J, Swartz R, Bergstrom J, Lindholm B, Lim V, Brunori G, Leiserowitz M, Bier DM, et al. Treatment of malnourished CAPD patients with an amino acid based dialysate. Kidney Int. 1995 Apr;47(4):1148-57. doi: 10.1038/ki.1995.164.
Tjiong HL, Swart R, van den Berg JW, Fieren MW. Amino Acid-based peritoneal dialysis solutions for malnutrition: new perspectives. Perit Dial Int. 2009 Jul-Aug;29(4):384-93.
Other Identifiers
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AAD-QSLK-401
Identifier Type: -
Identifier Source: org_study_id