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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Qingshan Likang Pharmaceutical Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • amino acid (15) peritoneal dialysis solution
  • glucose peritoneal dialysis solution

Treatment groups

400 Participants
are divided into 2 treatment groups