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.
Patients with end-stage renal disease (ESRD) have high morbidity and mortality. Current dialysis poorly clears protein-bound uremic toxins (PBUTs) such as indoxyl sulfate (IS), which is associated with adverse outcomes. Coated Aldehyde Oxystarch is an oral adsorbent that binds IS in vitro, but its in vivo effect is unknown. This study aims to rigorously explore the effect of Coated Aldehyde Oxystarch on reducing serum IS and other PBUTs in maintenance hemodialysis patients. This is the first in vivo study to evaluate the effect of Coated Aldehyde Oxystarch on reducing protein-bound uremic toxins (particularly indoxyl sulfate) in patients with end-stage renal disease, offering a novel intestinal-targeted strategy to mitigate toxin accumulation in dialysis patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Each capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months.
Peking University People's Hospital
Beijing, China
RECRUITINGAbsolute 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.
Time frame: Baseline, Month 3
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%.
Time frame: Baseline, Month 3
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.
Time frame: Baseline, Month 1, Month 2, Month 3
Changes in Serum Phosphorus Levels
Change from baseline in serum phosphorus levels at Month 1, Month 2, and Month 3.
Time frame: Baseline, Month 1, Month 2, Month 3
Changes in Serum Calcium Levels
Change from baseline in serum calcium levels at Month 1, Month 2, and Month 3.
Time frame: Baseline, Month 1, Month 2, Month 3
Changes in Serum Potassium Levels
Change from baseline in serum potassium levels at Month 1, Month 2, and Month 3.
Time frame: Baseline, Month 1, Month 2, Month 3
Change in High-Sensitivity C-Reactive Protein (hs-CRP) Level
Change from baseline in serum hs-CRP level at Month 1, Month 2, and Month 3.
Time frame: Baseline, Month 1, Month 2, Month 3
Change From Baseline in Worst Itch Numeric Rating Scale Score Over Time
The change from baseline in pruritus severity associated with chronic kidney disease will be assessed using the Worst Itch Numeric Rating Scale at Month 1, Month 2, and Month 3. The Worst Itch Numeric Rating Scale ranges from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch. Higher scores indicate more severe pruritus.
Time frame: Baseline, Month 1, Month 2, Month 3
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