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A multicenter, open label, prospective, self controlled clinical study of amino acid peritoneal dialysis fluid

Exploring the effectiveness and safety of amino acid peritoneal dialysis solution in improving the nutritional status of maintenance peritoneal dialysis patients: a multicenter, open label, prospective, self controlled clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108808
Enrollment
Unknown
Registered
2025-09-05
Start date
2023-12-05
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maintenance peritoneal dialysis with malnutrition in end-stage renal disease.

Interventions

Amino acid peritoneal dialysis solution group:None

Sponsors

The People's Hospital gaozhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Urinary patients with malnutrition during the screening period should undergo maintenance peritoneal dialysis for at least 3 months. The criteria for malnutrition must meet at least two of the following criteria: (1) serum albumin level7 points; 2.Blood urea nitrogen <= 38mmol/L; 3.The patient's age is between 18 and 75 years old; 4.Patient signs informed consent form;

Exclusion criteria

Exclusion criteria: 1.Individuals who are allergic to any amino acids or excipients in this product; 2.More than one occurrence of peritonitis within the past three months; Peritonitis or hospitalization within the past month; 3.Merge hyperthyroidism, systemic infections, fever, and other high catabolic metabolic diseases, as well as taking drugs that affect tissue metabolism, such as corticosteroids; 4.Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia; 5.Individuals with malignant tumor metastasis or spread, residual cancer lesions after treatment, coagulation dysfunction, aplastic anemia, and other serious systemic diseases such as heart, brain, and lung; 6.Possible kidney transplant during the trial period; 7.Hepatitis B or active hepatitis C, cirrhosis, active liver disease, liver dysfunction, or positive serum reaction for human immunodeficiency virus (HIV); 8.Individuals who have participated in clinical trials of other drugs within the three months prior to enrollment; 9.Pregnant and lactating women; 10.Mentally unable to cooperate; 11.Unsigned written informed consent form; 12.Unable or unwilling to comply with the experimental protocol recognized by the researcher.

Design outcomes

Primary

MeasureTime frame
Albumin;prealbumin;

Secondary

MeasureTime frame
weight;body mass index;conicity index;waist circumference;Upper arm muscle circumference;Normalized protein catabolic rate;Normalized protein nitrogen appearance;glycosylated hemoglobin;Fasting blood glucose;Urine output;Peritoneal dialysis ultrafiltration volume;Kt/V;Ccr;peritoneal equilibration test;

Countries

China

Contacts

Public ContactShanshan Deng

The People's Hospital gaozhou

276531255@qq.com+86 668 662 2919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026