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.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. 18 to 75 years of age (including 18 and 75 years of age), regardless of sex;
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:
1. 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;
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.
Primary outcome measure(s)
ALB — After 90 days of treatment 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).
Trial sites (21)
Facility
City
Region
Status
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Recruiting
Peking University People&'s Hospital
Beijing
Beijing Municipality
Recruiting
Wuhan NO.1 Hospital
Wuhan
Hubei
Recruiting
The Third Xiangya Hospital of Central South University
Changsha
Hunan
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
China
Recruiting
Ganzhou People&#39;s Hospital
Ganzhou
China
Recruiting
Affiliated Hospital of Guangdong Medical University
Guangdong
China
Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou
China
Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou
China
Recruiting
Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)
Meishan
China
Recruiting
Jiangsu Province Hosipital
Nanjing
China
Recruiting
The Affiliated Hospital of Nanjing university Medical School
Nanjing
China
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
China
Recruiting
Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai JiaoTong University
Shanghai
China
Recruiting
General Hospital of Northern Theater Command
Shenyang
China
Recruiting
The Central Hospital of Wuhan
Wuhan
China
Recruiting
Zhongshan Hospital Xiamen University
Xiamen
China
Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang
China
Recruiting
The Second People's Hospital of Yibin City
Yibin
China
Recruiting
The First Affiliated Hospital of Zhengzhou University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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