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

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• ALB [Срок оценки: After 90 days of treatment]

Вторичные конечные точки (8)

• serum transferrin [Срок оценки: After 30, 60, and 90 days of treatment]
• arm muscle circumference (AMC) [Срок оценки: After 90 days of treatment]
• standardized protein nitrogen occurrence rate (nPNA) [Срок оценки: After 90 days of treatment]
• subjective comprehensive nutritional assessment (SGA) [Срок оценки: After 90 days of treatment]
• middle arm muscle circumference (MAMC) [Срок оценки: After 90 days of treatment]
• serum prealbumin [Срок оценки: After 30, 60, and 90 days of treatment]
• serum albumin [Срок оценки: After 30, 60, and 90 days of treatment]
• body mass index (BMI) [Срок оценки: After 90 days of treatment]

Критерии участия

Критерии включения

• 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
• C-reactive protein (CRP) ≤ 2 x upper limit of normal (ULN);
• Carbon dioxide binding capacity >18 mmol/L;
• 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.

Критерии исключения

• 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;
• Patients who have used amino acid (15) peritoneal dialysate within 6 months prior to the screening period.
• 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.
• 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);
• 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;
• Suffers from a malignant tumor or has a life expectancy of \&lt;6 months;
• Routine daily use of 4.25% glucose dialysis solution during the screening period;
• Diabetic subjects with poor prior glycemic control, e.g., HbAlc > 8%;
• Women during pregnancy or breastfeeding;
• Other circumstances that, in the opinion of the investigator, may make participation in this study inappropriate.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 21 центр

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Peking University People&amp;&#39;s Hospital — Пекин
• Wuhan NO.1 Hospital — Ухань
• The Third Xiangya Hospital of Central South University — Чанша
• West China Hospital, Sichuan University — Чэнду
• The Second Affiliated Hospital of Chongqing Medical University — Чунцин
• Ganzhou People&amp;#39;s Hospital — Ganzhou
• Affiliated Hospital of Guangdong Medical University — Guangdong
• … и ещё 13 центров

Публикации

• My Thuc LT, Dung NQ, Ha VN, Tam ND, Hang Nga NT. Actual diet and nutritional deficiencies status in children on peritoneal dialysis at the Vietnam National Hospital of Pediatrics. Saudi J Kidney Dis Transpl. 2019 Jul-Aug;30(4):924-931. doi: 10.4103/1319-2442.265470. PMID 31464251
• Kopple JD, Bernard D, Messana J, Swartz R, Bergstrom J, Lindholm B, Lim V, Brunori G, Leiserowitz M, Bier DM, et al. Treatment of malnourished CAPD patients with an amino acid based dialysate. Kidney Int. 1995 Apr;47(4):1148-57. doi: 10.1038/ki.1995.164. PMID 7783413
• Tjiong HL, Swart R, van den Berg JW, Fieren MW. Amino Acid-based peritoneal dialysis solutions for malnutrition: new perspectives. Perit Dial Int. 2009 Jul-Aug;29(4):384-93. PMID 19602603

Идентификаторы

NCT: NCT06597201 · AAD-QSLK-401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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