Clinical trial NCT06597201: Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: End Stage Renal Disease (ESRD)
Keywords: End stage renal disease
peritoneal dialysis solution
malnutrition
Lead sponsor: Chengdu Qingshan Likang Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ALB
timeFrame: After 90 days of treatment
Secondary outcomes:
measure: serum transferrin
timeFrame: After 30, 60, and 90 days of treatment
measure: arm muscle circumference (AMC)
timeFrame: After 90 days of treatment
measure: standardized protein nitrogen occurrence rate (nPNA)
timeFrame: After 90 days of treatment
measure: subjective comprehensive nutritional assessment (SGA)
timeFrame: After 90 days of treatment
measure: middle arm muscle circumference (MAMC)
timeFrame: After 90 days of treatment
measure: serum prealbumin
timeFrame: After 30, 60, and 90 days of treatment
measure: serum albumin
timeFrame: After 30, 60, and 90 days of treatment
measure: body mass index (BMI)
timeFrame: After 90 days of treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University People&amp;&#39;s Hospital
state: Beijing
city: Wuhan
country: China
facility: Wuhan NO.1 Hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Ganzhou
country: China
facility: Ganzhou People&amp;#39;s Hospital
city: Guangdong
country: China
facility: Affiliated Hospital of Guangdong Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
city: Meishan
country: China
facility: Meishan Hospital, West China Hospital, Sichuan University (Meishan People&#39;s Hospital)
city: Nanjing
country: China
facility: Jiangsu Province Hosipital
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing university Medical School
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Shanghai Sixth People&amp;amp;#39;s Hospital Affiliated to Shanghai JiaoTong University
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical College
city: Yibin
country: China
facility: The Second People&#39;s Hospital of Yibin City
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: 四川
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.