Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution

NCT ID: NCT06358820

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-03
• Study Completion Date: 2025-01-07

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Self Control

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

Group Type: OTHER

Amino acid peritoneal dialysis solution

Intervention Type: 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

Interventions

Amino acid peritoneal dialysis solution

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Blood urea nitrogen ≤ 38mmol/L;

3. The patient's age is between 18 and 75 years old;

4. The patient signs an informed consent form.

Exclusion Criteria

1. Individuals who are allergic to any amino acids or excipients in this product

2. More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;

3. 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;

4. 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;

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The People's Hospital of Gaozhou

OTHER

Sponsor Role: lead

Responsible Party

deng shanshan

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gaozhou People's Hospital

Gaozhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 40864356 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PHGaozhou

Identifier Type: -

Identifier Source: org_study_id