Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
Coated Aldehyde Oxystarch: Each capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3 — Baseline, 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 — Baseline, 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%.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | China | Recruiting |
More Peking University People's Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07653711 on ClinicalTrials.gov ↗ ← All trials in China