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Multicenter, prospective, open-label, randomized, parallel-group clinical trial to evaluate the efficacy and safety of Amino Acid (15) peritoneal dialysis solution in peritoneal dialysis patients with malnutrition.

Multicenter, prospective, open-label, randomized, parallel-group clinical trial to evaluate the efficacy and safety of Amino Acid (15) peritoneal dialysis solution in peritoneal dialysis patients with malnutrition.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088333
Enrollment
Unknown
Registered
2024-08-15
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

End stage renal disease of chronic kidney disease

Interventions

experimental group:Subjects were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
control group:Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 to 75 years of age (including 18 and 75 years of age), regardless of sex; 2. Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months; 3. Urine volume = 500 ml/d 4. 25 = serum ALB = 35 g/L on two consecutive occasions prior to enrollment (two occasions one week apart); 5. Blood potassium = 3.5 mmol/L 6. C-reactive protein (CRP) = 2 x upper limit of normal (ULN); 7. Carbon dioxide binding capacity > 22 mmol/L; 8. Subjects voluntarily sign an informed consent form in writing prior to the commencement of any procedures related to the study, fully understand the purpose and significance of the trial, and are willing to comply with the trial protocol.

Exclusion criteria

Exclusion criteria: 1. Have had peritonitis, other infections or inflammatory diseases with documented hospitalization within 3 months prior to the screening period; 2. The possibility of receiving a kidney transplant during the study period; 3. patients with contraindications to amino acid (15) peritoneal dialysis solutions: 1) hypersensitivity to any of the components of the product; 2) Serum urea level >38 mmol/l; 3) Presence of uremic symptoms such as marked loss of appetite, nausea and vomiting at the time of screening; 4) Various inborn abnormalities of amino acid metabolism; 5) hepatic insufficiency (active hepatitis); active hepatitis B or C, cirrhosis, active liver disease or positive seropositivity for human immunodeficiency virus (HIV) within 6 months prior to screening; 6) Uncorrectable mechanical defects that the investigator assesses as affecting efficacy or increasing the risk of infection; 7) History of loss of peritoneal function or impairment of peritoneal function due to extensive adhesions; 4. Suffers from a malignant tumor or has a life expectancy of 8%; 7. Women during pregnancy or breastfeeding; 8. Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.

Design outcomes

Primary

MeasureTime frame
ALB;

Countries

China

Contacts

Public ContactPing Fu

West China Hospital, Sichuan University

fupinghx@163.com+86 189 8060 1201

Outcome results

None listed

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