The goal of this clinical trial is to learn if Coated Aldehyde Oxystarch (Xiqing) works to reduce protein-bound uremic toxins (PBUTs) in adults with end-stage renal disease (ESRD). It will also learn about the safety of Coated Aldehyde Oxystarch. The main questions it aims to answer are:
Does Coated Aldehyde Oxystarch lower the blood levels of protein-bound uremic toxins, such as indoxyl sulfate and p-cresyl sulfate?
What medical problems do participants have when taking Coated Aldehyde Oxystarch?
Researchers will compare the levels of PBUTs before treatment (baseline) with those after treatment with Coated Aldehyde Oxystarch to see if it works to reduce these toxins.
Participants will:
Take Coated Aldehyde Oxystarch (Xiqing) 10 capsules per time, three times daily (each capsule 0.625 g, total daily dose 18.75 g) for 3 months.
Visit the clinic every month for checkups and blood tests.
Provide blood samples to measure protein-bound uremic toxin levels and routine safety parameters.
Age ≥ 18 years, no restriction on sex or ethnicity.
Receiving maintenance dialysis for at least 3 months, with dialysis regimen remaining unchanged during the trial period.
If taking other medications that do not interfere with gut microbiota prior to enrollment, they must have been stable for at least 1 month and the regimen must remain unchanged during the trial.
Ability to understand and voluntarily sign the informed consent form.
Known allergy to Coated Aldehyde Oxystarch.
History of or planned kidney transplantation within 6 months, or change in dialysis regimen.
Use of medications or supplements that may affect gut microbiota (e.g., antibiotics, probiotics, prebiotics, laxatives) within the past 3 months.
Diagnosis of serious gastrointestinal diseases, including gastrointestinal bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, history of intestinal obstruction, history of gastrectomy or duodenectomy.
Single group
Coated Aldehyde Oxystarch
DrugEach capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months.
Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
The absolute change in serum indoxyl sulfate (IS) level from baseline to Month 3 will be calculated as the serum IS level at Month 3 minus the serum IS level at baseline.
Percentage Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
The percentage change in serum indoxyl sulfate (IS) level from baseline to Month 3 will be calculated as: \[(serum IS level at Month 3 - serum IS level at baseline) / serum IS level at baseline\] × 100%.
Change in Serum Indoxyl Sulfate (IS) Level Over Time
Change from baseline in serum IS level at Month 1 and Month 2, in addition to Month 3. The trend of changes over different time points will be analyzed.
Changes in Serum Phosphorus Levels
Change from baseline in serum phosphorus levels at Month 1, Month 2, and Month 3.
Changes in Serum Calcium Levels
Change from baseline in serum calcium levels at Month 1, Month 2, and Month 3.
Changes in Serum Potassium Levels
Change from baseline in serum potassium levels at Month 1, Month 2, and Month 3.
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