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.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 21
- 主要终点
- ALB
研究概览
简要总结
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.
详细描述
After the subjects signed the informed consent, they entered the screening period (D-28 to D-1) for corresponding examination. Participants who were successfully screened were examined at baseline (D-3 to D-1) to re-verify the inclusion criteria. After re-verification of successful screening subjects, they were enrolled in 1:1 parallel groups according to the research center: experimental group treated with amino acid (15) peritoneal dialysate; Control group - glucose peritoneal dialysate treatment. Subjects were randomly enrolled and given the experimental drug from the next morning according to the randomized results. Subjects in the experimental group were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once a day in the morning, and were subsequently treated with conventional glucose peritoneal dialysate (lactate). Control subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysis solution (lactate) (2L) once. The number of peritoneal dialysate exchange, the amount of fluid exchange and the duration of abdominal retention were adjusted by the researchers according to the specific conditions of the patients. Efficacy and safety were observed during the treatment period (D1-D90). Blood routine and blood biochemistry were monitored for 30 days, 60 days and 90 days of treatment. nPNA, AMC, MAMC, SGA, BMI, Kt/V, etc. are monitored only at 90 days. The total daily ultrafiltration volume of the patients (the experimental group also recorded the ultrafiltration volume of amino acid peritoneal fluid), and all adverse events (aes) and serious adverse events (SAEs) were recorded in detail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 with inadequate dialysis and screening period kt/v<1.4;
- •Patients with hemoglobin less than 80g/L during the screening 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.
- •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);
- •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;
- •Suffers from a malignant tumor or has a life expectancy of <6 months;
- •Routine daily use of 4.25% glucose dialysis solution during the screening period;
- •Diabetic subjects with poor prior glycemic control, e.g., HbAlc > 8%;
- •Women during pregnancy or breastfeeding;
- •Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.
研究组 & 干预措施
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).
干预措施: amino acid (15) peritoneal dialysis solution (Drug)
control group
Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.
干预措施: glucose peritoneal dialysis solution (Drug)
结局指标
主要结局
ALB
时间窗: 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).
次要结局
- serum transferrin(After 30, 60, and 90 days of treatment)
- arm muscle circumference (AMC)(After 90 days of treatment)
- standardized protein nitrogen occurrence rate (nPNA)(After 90 days of treatment)
- subjective comprehensive nutritional assessment (SGA)(After 90 days of treatment)
- middle arm muscle circumference (MAMC)(After 90 days of treatment)
- serum prealbumin(After 30, 60, and 90 days of treatment)
- serum albumin(After 30, 60, and 90 days of treatment)
- body mass index (BMI)(After 90 days of treatment)