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

Last updated: December 27, 2024
Sponsor: Chengdu Qingshan Likang Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

4

Condition

Diet And Nutrition

Weight Loss

Treatment

amino acid (15) peritoneal dialysis solution

glucose peritoneal dialysis solution

Clinical Study ID

NCT06597201
AAD-QSLK-401
  • Ages 18-75
  • All Genders

Study Summary

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

Inclusion

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 3months;

  3. 25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (twooccasions 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 thecommencement of any procedures related to the study, fully understand the purposeand significance of the trial, and are willing to comply with the trial protocol.

Exclusion

Exclusion Criteria:

  1. Within the past 3 months prior to the screening period, there has been a history ofperitonitis, other infections, or inflammatory diseases, with hospitalizationrecords;

  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 tothe screening period.

  6. Patients with bleeding events (active gastrointestinal hemorrhage, cerebralhemorrhage), cardiovascular and cerebrovascular events (cerebral infarction,myocardial infarction, etc., and NYHA grade ≥3 of cardiac function) within 30 daysbefore screening period.

  7. In patients with active diarrhea during the screening period, as assessed byinvestigators, affecting nutrient absorption(Except for patients with chronicdiarrhea, 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 >38mmol/l; 3) Presence of uremic symptoms such as marked loss of appetite, nausea andvomiting at the time of screening; 4) Various inborn abnormalities of amino acidmetabolism; 5) hepatic insufficiency (active hepatitis); active hepatitis B or C,cirrhosis, active liver disease or positive seropositivity for humanimmunodeficiency virus (HIV) within 6 months prior to screening; 6) Uncorrectablemechanical defects that the investigator assesses as affecting efficacy orincreasing the risk of infection; 7) History of loss of peritoneal function orimpairment 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 participationin this study inappropriate.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: amino acid (15) peritoneal dialysis solution
Phase: 4
Study Start date:
August 09, 2024
Estimated Completion Date:
June 29, 2025

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Active - Recruiting

  • Peking University People&amp;&#39;s Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Wuhan NO.1 Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, 四川 610000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • Ganzhou People&amp;#39;s Hospital

    Ganzhou,
    China

    Active - Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Guangdong,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou,
    China

    Active - Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou,
    China

    Active - Recruiting

  • Meishan Hospital, West China Hospital, Sichuan University (Meishan People&#39;s Hospital)

    Meishan,
    China

    Active - Recruiting

  • Jiangsu Province Hosipital

    Nanjing,
    China

    Active - Recruiting

  • The Affiliated Hospital of Nanjing university Medical School

    Nanjing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning,
    China

    Active - Recruiting

  • Shanghai Sixth People&amp;amp;#39;s Hospital Affiliated to Shanghai JiaoTong University

    Shanghai,
    China

    Active - Recruiting

  • General Hospital of Northern Theater Command

    Shenyang,
    China

    Active - Recruiting

  • The Central Hospital of Wuhan

    Wuhan,
    China

    Active - Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang,
    China

    Active - Recruiting

  • The Second People&#39;s Hospital of Yibin City

    Yibin,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Active - Recruiting

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