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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• History of cardiovascular or cerebrovascular events within 3 months prior to screening, including hospitalization for stroke, myocardial infarction, unstable angina, congestive heart failure; severe valvular stenosis, uncontrolled atrial fibrillation or arrhythmia; QTc interval >500 ms on repeated ECG.
• Concurrent severe primary diseases of cardiovascular, cerebrovascular, hepatic, hematopoietic systems, or other known life-threatening diseases (e.g., malignancy, AIDS), or patients with mental or legal disabilities.
• Investigator judges life expectancy ≤6 months.
• Inability to maintain stable dietary habits during the study period.
• Inability to maintain original dialysis regimen during the study period.
• Use of Chinese patent medicines for kidney disease (e.g., Shenkang Injection, Haikun Shenxi Capsule, Shenshuaining, Tripterygium preparations, Niaoduqing Granules) within 1 month prior to enrollment.
• Participation in another clinical trial within the past 1 month.
• Intellectual disability, psychiatric disorders, or suspected/confirmed history of alcohol or drug abuse that may affect compliance.
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.