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

December 27, 2024 updated by: Chengdu Qingshan Likang Pharmaceutical Co., Ltd

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Qian Deng
  • Phone Number: 86 136 9940 1416
  • Email: dq0416@qq.com

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Ganzhou, China
        • Recruiting
        • Ganzhou People's Hospital
        • Contact:
      • Guangdong, China
        • Recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Luzhou, China
        • Recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
      • Meishan, China
        • Recruiting
        • Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)
        • Contact:
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hosipital
        • Contact:
      • Nanjing, China
        • Recruiting
        • The Affiliated Hospital of Nanjing University Medical School
        • Contact:
      • Nanning, China
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
        • Contact:
      • Shenyang, China
        • Recruiting
        • General Hospital of Northern Theater Command
        • Contact:
      • Wuhan, China
        • Recruiting
        • The Central Hospital of Wuhan
        • Contact:
      • Xiamen, China
        • Recruiting
        • Zhongshan Hospital Xiamen University
        • Contact:
      • Xinxiang, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical College
        • Contact:
      • Yibin, China
        • Recruiting
        • The Second People's Hospital of Yibin City
        • Contact:
      • Zhengzhou, China
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Anhui
      • Hefei, Anhui, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People&'s Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Wuhan No.1 Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
    • 四川
      • Chengdu, 四川, China, 610000
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 <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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Subjects were treated with 1 bag of amino acid (15) peritoneal dialysate (2L) once every morning, and then with conventional glucose peritoneal dialysate (lactate).
Drug: 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).
Active Comparator: control group
Subjects received conventional treatment with glucose peritoneal dialysis solution (lactate), which must include 1.5% glucose peritoneal dialysate (lactate) (2L) once.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALB
Time Frame: After 90 days of treatment
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).
After 90 days of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum transferrin
Time Frame: After 30, 60, and 90 days of treatment
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.
After 30, 60, and 90 days of treatment
arm muscle circumference (AMC)
Time Frame: After 90 days of treatment
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.
After 90 days of treatment
standardized protein nitrogen occurrence rate (nPNA)
Time Frame: After 90 days of treatment
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.
After 90 days of treatment
subjective comprehensive nutritional assessment (SGA)
Time Frame: After 90 days of treatment
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.
After 90 days of treatment
middle arm muscle circumference (MAMC)
Time Frame: After 90 days of treatment
To compare the change of middle arm muscle circumference (MAMC) in CAPD patients treated with amino acid (15) peritoneal dialysis solution and conventional glucose peritoneal dialysis solution (lactate) after 90 days from baseline.
After 90 days of treatment
serum prealbumin
Time Frame: After 30, 60, and 90 days of treatment
To compare the changes of serum prealbumin 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.
After 30, 60, and 90 days of treatment
serum albumin
Time Frame: After 30, 60, and 90 days of treatment
To compare the changes of serum albumin 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.
After 30, 60, and 90 days of treatment
body mass index (BMI)
Time Frame: After 90 days of treatment
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.
After 90 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Qingshan Likang Pharmaceutical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2024

Primary Completion (Estimated)

June 29, 2025

Study Completion (Estimated)

June 29, 2025

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 11, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAD-QSLK-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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