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临床试验/NCT07370441
NCT07370441Enrolling By Invitation4 期

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

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年5月1日最近更新:
干预措施

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:

  1. Can Amino Acid (15) Peritoneal Dialysis Solution raise the level of serum albumin (a key indicator of nutritional status) in participants?
  2. How does this solution affect participants' dialysis adequacy and peritoneal transport function?
  3. 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:

  1. 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.
  2. 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.
  3. Attend follow-up visits every 2 weeks to record dialysis-related data (such as ultrafiltration volume) and any uncomfortable symptoms or adverse reactions.
  4. 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

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

Experimental

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

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen Xue MD, PhD

Attending Physician

Shanghai 10th People's Hospital

研究点 (1)

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