Phase
Condition
Diet And Nutrition
Weight Loss
Treatment
amino acid (15) peritoneal dialysis solution
glucose peritoneal dialysis solution
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 3months;
25 ≤ serum ALB ≤ 40 g/L on two consecutive occasions prior to enrollment (twooccasions 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 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:
Within the past 3 months prior to the screening period, there has been a history ofperitonitis, other infections, or inflammatory diseases, with hospitalizationrecords;
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 tothe screening period.
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.
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);
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;
Suffers from a malignant tumor or has a life expectancy of <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 participationin this study inappropriate.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230022
ChinaActive - Recruiting
Peking University People&'s Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
Wuhan NO.1 Hospital
Wuhan, Hubei
ChinaActive - Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan 410000
ChinaActive - Recruiting
West China Hospital, Sichuan University
Chengdu, 四川 610000
ChinaActive - Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing,
ChinaActive - Recruiting
Ganzhou People&#39;s Hospital
Ganzhou,
ChinaActive - Recruiting
Affiliated Hospital of Guangdong Medical University
Guangdong,
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou,
ChinaActive - Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou,
ChinaActive - Recruiting
Meishan Hospital, West China Hospital, Sichuan University (Meishan People's Hospital)
Meishan,
ChinaActive - Recruiting
Jiangsu Province Hosipital
Nanjing,
ChinaActive - Recruiting
The Affiliated Hospital of Nanjing university Medical School
Nanjing,
ChinaActive - Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning,
ChinaActive - Recruiting
Shanghai Sixth People&amp;#39;s Hospital Affiliated to Shanghai JiaoTong University
Shanghai,
ChinaActive - Recruiting
General Hospital of Northern Theater Command
Shenyang,
ChinaActive - Recruiting
The Central Hospital of Wuhan
Wuhan,
ChinaActive - Recruiting
Zhongshan Hospital Xiamen University
Xiamen,
ChinaActive - Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang,
ChinaActive - Recruiting
The Second People's Hospital of Yibin City
Yibin,
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.