Evaluating a new amino acid dialysis solution for malnourished patients on peritoneal dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, parallel controlled Phase IV clinical study aims to assess the safety and efficacy of an amino acid (15) peritoneal dialysis solution in patients with end-stage renal disease (ESRD) who are undergoing peritoneal dialysis and experiencing malnutrition. Participants will be randomly assigned to receive either the amino acid solution or a conventional glucose-based solution for a treatment period of 90 days. Various health parameters, including blood biochemistry and nutritional status, will be monitored throughout the study to evaluate the outcomes of the interventions.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Peking University People&'s Hospital
  Beijing, Beijing Municipality, China Recruiting
• Wuhan NO.1 Hospital
  Wuhan, Hubei, China Recruiting
• The Third Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting
• The Second Affiliated Hospital of Chongqing Medical University
  Chongqing, China Recruiting

Study contacts

• Study coordinator: Qian Deng
• Email: dq0416@qq.com
• Phone: 86 136 9940 1416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.