A Single-Center, Prospective, Open-Label, Self-Controlled Clinical Study on the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Improving Nutritional Status in Peritoneal Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum Albumin (Alb)
研究概览
简要总结
The goal of this clinical trial is to assess whether Amino Acid (15) Peritoneal Dialysis Solution can improve the nutritional status of adults with end-stage kidney disease who have received peritoneal dialysis for 6 months or longer. It will also observe the solution's effects on dialysis adequacy and peritoneal transport function, as well as monitor its short-term safety. The main questions it aims to answer are:
- Can Amino Acid (15) Peritoneal Dialysis Solution raise the level of serum albumin (a key indicator of nutritional status) in participants?
- How does this solution affect participants' dialysis adequacy and peritoneal transport function?
- What adverse reactions might participants experience when using this solution? This is a single-arm study with a self-controlled design. Researchers will compare participants' health indicators before and after the intervention to evaluate the solution's effectiveness and safety.
Participants will:
- Continue their original peritoneal dialysis routine, replacing one bag of dialysis solution with Amino Acid (15) Peritoneal Dialysis Solution (2L per bag) after lunch every day for 6 months.
- Undergo comprehensive health checks (including blood tests, nutritional status assessments, and peritoneal function evaluations) on the enrollment day (baseline), as well as at 3 and 6 months after the intervention.
- Attend follow-up visits every 2 weeks to record dialysis-related data (such as ultrafiltration volume) and any uncomfortable symptoms or adverse reactions.
- Maintain stable doses of medications affecting protein metabolism and nutritional supplements throughout the study; report to researchers immediately if any dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older.
- •Have received peritoneal dialysis for 6 months or longer.
- •Serum albumin level < 38 g/L.
- •No history of peritonitis in the past 3 months and no hospitalization in the past 1 month.
- •No severe heart, liver, kidney diseases, or malignant tumors.
- •Expected survival time > 1 year.
- •Good compliance and willingness to sign the informed consent form.
- •Diagnosed with end-stage renal disease (ESRD) with an estimated glomerular filtration rate (eGFR) < 15 mL/(min·1.73 m²).
排除标准
- •Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or any of its components.
- •Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal).
- •Taking medications that affect protein metabolism and unable to maintain a stable dose during the study period.
- •Need for adjustment of nutritional supplement doses during the study.
- •Uncorrectable severe gastrointestinal reactions.
- •Pregnant, lactating, or planning to undergo kidney transplantation.
研究组 & 干预措施
Amino Acid (15) PD Solution for Nutritional Support
All participants will receive a uniform intervention: Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch.
干预措施: amino acid (15) peritoneal dialysis solution (Drug)
结局指标
主要结局
Serum Albumin (Alb)
时间窗: At baseline (enrollment day), at 3 months into the intervention, and at the end of the 6-month intervention period
次要结局
未报告次要终点
研究者
Wen Xue MD, PhD
Attending Physician
Shanghai 10th People's Hospital
