This is a multicenter, randomized, parallel controlled Phase IV clinical study to evaluate the safety and efficacy of amino acid (15) peritoneal dialysis solution in patients undergoing peritoneal dialysis with malnutrition in CAPD patients undergoing peritoneal dialysis maintenance.
18 to 75 years of age (including 18 and 75 years of age), regardless of sex;
Stable CAPD patients treated with peritoneal dialysis for greater than or equal to 3 months;
25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart);
Blood potassium ≥ 3.5 mmol/L
Within the past 3 months prior to the screening period, there has been a history of peritonitis, other infections, or inflammatory diseases, with hospitalization records;
The possibility of receiving a kidney transplant during the study period;
Patients with inadequate dialysis and screening period kt/v<1.4;
Patients with hemoglobin less than 80g/L during the screening period;
Parallel
amino acid (15) peritoneal dialysis solution
DrugSubjects were treated with 1 bag of amino acid (15) peritoneal dialysis solution (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
glucose peritoneal dialysis solution
DrugSubjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.
ALB
To compare the difference in change from baseline in serum albumin (ALB) after 90 days of treatment of CAPD patients with amino acid (15) peritoneal dialysis solution versus conventional glucose peritoneal dialysis solution (lactate).
serum transferrin
To compare the changes of serum transferrin in CAPD patients treated with amino acid (15) peritoneal dialysate and conventional glucose peritoneal dialysate (lactate) at 30 days, 60 days and 90 days compared with baseline.
arm muscle circumference (AMC)
omparison of standardized upper arm muscle circumference (AMC) changes from baseline after fasting peritoneal dialysis fluid emptying between amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) in CAPD patients treated for 90 days.
standardized protein nitrogen occurrence rate (nPNA)
To compare the change of standardized protein nitrogen occurrence rate (nPNA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
subjective comprehensive nutritional assessment (SGA)
To compare the change of subjective comprehensive nutritional assessment (SGA) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
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