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Tests treatment safety and results for End Stage Renal Disease (ESRD)
Official title Evaluate the Efficacy and Safety of Amino Acid (15) Peritoneal Dialysis Solution in Peritoneal Dialysis Patients with Malnutrition.
ClinicalTrials.gov ID: NCT06597201
What this study is testing
What is amino acid (15) peritoneal dialysis solution?
amino acid (15) peritoneal dialysis solution is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for end stage renal disease (esrd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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 3 months;
- 25 ≤ 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);
You likely can't join if
- Within the past 3 months prior to the screening period, there has been a history of peritonitis, other infections, or inflammatory diseases, with...
- 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...
See the full eligibility 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 3 months;
- 25 ≤ 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;
- people 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...
- 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...
- 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...
- 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Chengdu, Sichuan, China
- Chongqing, China
- Ganzhou, China
- Guangdong, China
- Guangzhou, China
- Luzhou, China
- Meishan, China
- Nanjing, China
- Nanning, China
- Shanghai, China
- Shenyang, China
- Wuhan, China
- Xiamen, China
- Xinxiang, China
- Yibin, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Wuhan, Hubei, China; Changsha, Hunan, China; Chengdu, Sichuan, China; Chongqing, China and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.