NCT07370441Enrolling by invitationPhase 4
Amino Acid (15) Peritoneal Dialysis Solution for Nutritional Improvement in Peritoneal Dialysis Patients
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
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 Jan 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Shanghai 10th People's Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07370441
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 1 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking medications that affect protein metabolism and unable to maintain a stable dose during the study period.
- Pregnant, lactating, or planning to undergo kidney transplantation.
Other illness
- Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or any of its components.
Lab values
- Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal).
Other
- Need for adjustment of nutritional supplement doses during the study.
- Uncorrectable severe gastrointestinal reactions.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.