Amino Acid (15) Peritoneal Dialysis Solution for Nutritional Improvement in Peritoneal Dialysis Patients (AA15-PD-Nut-SH)

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Nutritional Status; Renal Replacement Therapy; End-stage Renal Disease (ESRD); Peritoneal Dialysis (PD)
• Intervention / Treatment: Drug: amino acid (15) peritoneal dialysis solution

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200072
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 years or older.
2. Have received peritoneal dialysis for 6 months or longer.
3. Serum albumin level < 38 g/L.
4. No history of peritonitis in the past 3 months and no hospitalization in the past 1 month.
5. No severe heart, liver, kidney diseases, or malignant tumors.
6. Expected survival time > 1 year.
7. Good compliance and willingness to sign the informed consent form.
8. Diagnosed with end-stage renal disease (ESRD) with an estimated glomerular filtration rate (eGFR) < 15 mL/(min·1.73 m²).

Exclusion Criteria:

1. Hypersensitivity or allergy to Amino Acid (15) Peritoneal Dialysis Solution or any of its components.
2. Hepatic dysfunction (ALT/AST ≥ 2 times the upper limit of normal).
3. Taking medications that affect protein metabolism and unable to maintain a stable dose during the study period.
4. Need for adjustment of nutritional supplement doses during the study.
5. Uncorrectable severe gastrointestinal reactions.
6. Pregnant, lactating, or planning to undergo kidney transplantation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: amino acid (15) peritoneal dialysis solution; Amino Acid (15) Peritoneal Dialysis Solution replacement therapy, administered at a regular dose of 2L per session, once daily after lunch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Albumin (Alb)	At baseline (enrollment day), at 3 months into the intervention, and at the end of the 6-month intervention period

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Pharmaceutical Solutions; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Solutions; Specialty Uses of Chemicals; Dialysis Solutions; Amino Acids
• Other Study ID Numbers: SH10H-AA15-PD-Nutrition

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No