Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution

NCT06358820 | Completed Phase 4 Results

• 1 other identifier: PHGaozhou
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded.

Conditions

Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution

Keywords

amino acid peritoneal dialysis solution；peritoneal dialysis

Outcome Measures

Primary Outcomes (2)

• Blood Albumin

  Changes in blood albumin levels

  6 months

• Prealbumin

  Changes in blood prealbumin levels

  6 months

Study Arms (1)

Self Control

OTHER

Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.

Drug: Amino acid peritoneal dialysis solution

Interventions

Amino acid peritoneal dialysis solution DRUG

Each subject received treatment with 1 bag of amino acid peritoneal dialysis daily and 2-4 bags of glucose peritoneal dialysis solution daily for 6 months

Self Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level\<3.5g/dL (35g/L), (2) prealbumin\<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of\>7;
• Blood urea nitrogen ≤ 38mmol/L;
• The patient's age is between 18 and 75 years old;
• The patient signs an informed consent form.

You may not qualify if:

• Individuals who are allergic to any amino acids or excipients in this product
• More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;
• Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids;
• Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia 5. Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases;
• \. Possible kidney transplantation during the trial period; 7. Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV); 8. Those who have participated in clinical trials of other drugs within the three months prior to enrollment; 9. Pregnant and lactating women; 10. Those who are mentally unable to cooperate; 11. Failure to sign a written informed consent form; 12. Unable or unwilling to comply with the experimental protocol approved by the researcher.

Sponsors & Collaborators

• The People's Hospital of Gaozhou: lead

Study Sites (1)

Gaozhou People's Hospital

Gaozhou, Guangdong, 525200, China

Location

Related Publications (1)

• Deng S, Xuan H, Chen L, Su X, Su Y, Lu Y, Zhu M, Yang X, Luo C, Shi W. Overnight-dwelled amino acid-based peritoneal dialysis solutions for malnutrition in CAPD: a prospective real-world study. Int Urol Nephrol. 2025 Aug 27. doi: 10.1007/s11255-025-04749-y. Online ahead of print.

  PMID: 40864356 DERIVED

Results Point of Contact

• Title: Shanshan Deng
• Organization: Gaozhou People's Hospital

276531255@qq.com

13927596600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: December 3, 2023
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: July 16, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)