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

Chengdu Qingshan Likang Pharmaceutical Co., Ltd

Status and phase: Enrolling; Phase 4

Conditions: End Stage Renal Disease (ESRD)

Treatments: Drug: glucose peritoneal dialysis solution; Drug: amino acid (15) peritoneal dialysis solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06597201

AAD-QSLK-401

Details and patient eligibility

About

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.

Full description

After the subjects signed the informed consent, they entered the screening period (D-28 to D-1) for corresponding examination. Participants who were successfully screened were examined at baseline (D-3 to D-1) to re-verify the inclusion criteria. After re-verification of successful screening subjects, they were enrolled in 1:1 parallel groups according to the research center: experimental group treated with amino acid (15) peritoneal dialysate; Control group - glucose peritoneal dialysate treatment. Subjects were randomly enrolled and given the experimental drug from the next morning according to the randomized results. Subjects in the experimental group were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once a day in the morning, and were subsequently treated with conventional glucose peritoneal dialysate (lactate). Control subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysis solution (lactate) (2L) once. The number of peritoneal dialysate exchange, the amount of fluid exchange and the duration of abdominal retention were adjusted by the researchers according to the specific conditions of the patients. Efficacy and safety were observed during the treatment period (D1-D90). Blood routine and blood biochemistry were monitored for 30 days, 60 days and 90 days of treatment. nPNA, AMC, MAMC, SGA, BMI, Kt/V, etc. are monitored only at 90 days. The total daily ultrafiltration volume of the patients (the experimental group also recorded the ultrafiltration volume of amino acid peritoneal fluid), and all adverse events (aes) and serious adverse events (SAEs) were recorded in detail.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (two occasions one week apart);
4. Blood potassium ≥ 3.5 mmol/L
5. C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN);
6. Carbon dioxide binding capacity >18 mmol/L;
7. 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

1. 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;
2. The possibility of receiving a kidney transplant during the study period;
3. Patients with inadequate dialysis and screening period kt/v<1.4;
4. Patients with hemoglobin less than 80g/L during the screening period;
5. Patients who have used amino acid (15) peritoneal dialysate within 6 months prior to the screening period.
6. Patients with bleeding events (active gastrointestinal hemorrhage, cerebral hemorrhage), cardiovascular and cerebrovascular events (cerebral infarction, myocardial infarction, etc., and NYHA grade ≥3 of cardiac function) within 30 days before screening period.
7. In patients with active diarrhea during the screening period, as assessed by investigators, affecting nutrient absorption(Except for patients with chronic diarrhea, stool frequency < 3 times/day);
8. 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;
9. Suffers from a malignant tumor or has a life expectancy of &lt;6 months;
10. Routine daily use of 4.25% glucose dialysis solution during the screening period;
11. Diabetic subjects with poor prior glycemic control, e.g., HbAlc > 8%;
12. Women during pregnancy or breastfeeding;
13. Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

experimental group

Experimental group

Description:

Subjects were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).

Treatment:

Drug: amino acid (15) peritoneal dialysis solution

control group

Active Comparator group

Description:

Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.

Treatment:

Drug: glucose peritoneal dialysis solution