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

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 study is testing a new amino acid dialysis solution to see if it can help malnourished patients with kidney failure who are on peritoneal dialysis feel better compared to a standard treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chengdu Qingshan Likang Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 21 sites (Hefei, Anhui and 20 other locations)
• Trial ID: NCT06597201 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are stable CAPD patients aged 18 to 75 with specific serum albumin levels indicating malnutrition.

Not a fit: Patients with recent infections, inadequate dialysis, or those expecting a kidney transplant during the study may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this study could improve nutritional status and overall health outcomes for malnourished patients undergoing peritoneal dialysis.

How similar studies have performed: While similar studies have explored nutritional interventions in dialysis patients, the specific use of an amino acid-based solution in this context is relatively novel.

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.

Where this trial is running

Hefei, Anhui and 20 other locations

• 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)
• Ganzhou People'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'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'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's Hospital of Yibin City — Yibin, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Qian Deng

Conditions End Stage Renal Disease; End stage renal disease; peritoneal dialysis solution; malnutrition