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Completed

NCT Number: NCT06358820

Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gaozhou People's Hospital

Gaozhou, Guangdong, 525200, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Blood Albumin

    Time frame: 6 months

    Changes in blood albumin levels

  2. Prealbumin

    Time frame: 6 months

    Changes in blood prealbumin levels

Sponsors and collaborators

Lead sponsor

The People's Hospital of Gaozhou

Other

Registry information

Official study title

Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.