Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.

Phase 4

Recruiting

• Conditions: End Stage Renal Disease (ESRD)

• Registration Number: NCT06597201
• Lead Sponsor: Chengdu Qingshan Likang Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Inclusion Criteria:<br><br> 1. 18 to 75 years of age (including 18 and 75 years of age), regardless of sex;<br><br> 2. Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3<br> months;<br><br> 3. Urine volume = 500 ml/d<br><br> 4. 25 = serum ALB = 35 g/L on two consecutive occasions prior to enrollment (two<br> occasions one week apart);<br><br> 5. Blood potassium = 3.5 mmol/L<br><br> 6. C-reactive protein (CRP) = 2 x upper limit of normal (ULN);<br><br> 7. Carbon dioxide binding capacity &gt; 22 mmol/L;<br><br> 8. Subjects voluntarily sign an informed consent form in writing prior to the<br> commencement of any procedures related to the study, fully understand the purpose<br> and significance of the trial, and are willing to comply with the trial protocol.<br><br>Exclusion Criteria:<br><br> 1. Have had peritonitis, other infections or inflammatory diseases with documented<br> hospitalization within 3 months prior to the screening period;<br><br> 2. The possibility of receiving a kidney transplant during the study period;<br><br> 3. patients with contraindications to amino acid (15) peritoneal dialysis solutions: 1)<br> hypersensitivity to any of the components of the product; 2) Serum urea level >38<br> mmol/l; 3) Presence of uremic symptoms such as marked loss of appetite, nausea and<br> vomiting at the time of screening; 4) Various inborn abnormalities of amino acid<br> metabolism; 5) hepatic insufficiency (active hepatitis); active hepatitis B or C,<br> cirrhosis, active liver disease or positive seropositivity for human<br> immunodeficiency virus (HIV) within 6 months prior to screening; 6) Uncorrectable<br> mechanical defects that the investigator assesses as affecting efficacy or<br> increasing the risk of infection; 7) History of loss of peritoneal function or<br> impairment of peritoneal function due to extensive adhesions;<br><br> 4. Suffers from a malignant tumor or has a life expectancy of <6 months;<br><br> 5. Routine daily use of 4.25% glucose dialysis solution during the screening period;<br><br> 6. Diabetic subjects with poor prior glycemic control, e.g., HbAlc > 8%;<br><br> 7. Women during pregnancy or breastfeeding;<br><br> 8. Other circumstances that, in the opinion of the investigator, may make participation<br> in this study inappropriate.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ALB

Secondary Outcome Measures

Name	Time	Method
serum transferrin;arm muscle circumference (AMC);standardized protein nitrogen occurrence rate (nPNA);subjective comprehensive nutritional assessment (SGA);middle arm muscle circumference (MAMC);serum prealbumin;serum albumin;body mass index (BMI)