drugset / Trial / NCT07653711

Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease

NCT07653711 ↗

Recruiting 30 enrolled Peking University People's Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-04-21
Primary completion
2026-07
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Coated Aldehyde Oxystarch Other / unclassified 6.25 g —