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

NCT06597201 | Recruiting Phase 4

• 1 other identifier: AAD-QSLK-401
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

End Stage Renal Disease (ESRD)

Keywords

End stage renal disease; peritoneal dialysis solution; malnutrition

Outcome Measures

Primary Outcomes (1)

• ALB

  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 Outcomes (8)

• serum transferrin

  After 30, 60, and 90 days of treatment

• arm muscle circumference (AMC)

  After 90 days of treatment

• standardized protein nitrogen occurrence rate (nPNA)

  After 90 days of treatment

• subjective comprehensive nutritional assessment (SGA)

  After 90 days of treatment

• middle arm muscle circumference (MAMC)

  After 90 days of treatment

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

amino acid (15) peritoneal dialysis solution DRUG

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).

experimental group

glucose peritoneal dialysis solution DRUG

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

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Qingshan Likang Pharmaceutical Co., Ltd: lead

Study Sites (21)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

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

Beijing, Beijing Municipality, 100044, China

RECRUITING

Wuhan NO.1 Hospital

Wuhan, Hubei, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

Ganzhou People&amp;#39;s Hospital

Ganzhou, China

RECRUITING

Affiliated Hospital of Guangdong Medical University

Guangdong, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, China

RECRUITING

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

Meishan, China

RECRUITING

Jiangsu Province Hosipital

Nanjing, China

RECRUITING

The Affiliated Hospital of Nanjing university Medical School

Nanjing, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

RECRUITING

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

Shanghai, China

RECRUITING

General Hospital of Northern Theater Command

Shenyang, China

RECRUITING

The Central Hospital of Wuhan

Wuhan, China

RECRUITING

Zhongshan Hospital Xiamen University

Xiamen, China

RECRUITING

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, China

RECRUITING

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

Yibin, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Malnutrition

Interventions

Amino Acids; Dialysis Solutions

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Qian Deng

CONTACT

86 136 9940 1416; dq0416@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: August 9, 2024
• Primary Completion: June 29, 2025
• Study Completion: June 29, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (21)