Coated Aldehyde Oxystarch to lower PBUTs in adults on dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with end-stage renal disease on maintenance dialysis to see if Coated Aldehyde Oxystarch can reduce serum protein-bound uremic toxins, especially indoxyl sulfate. Participants take 18.75 g daily (10 capsules three times daily) for three months and have monthly clinic visits with safety and toxin level monitoring. The trial compares toxin levels before and after treatment to determine effectiveness and safety in this in vivo setting. It represents a novel intestinal-targeted approach to mitigate toxin accumulation in dialysis patients. The study is conducted at Peking University People's Hospital in Beijing with a lead sponsor from the same institution.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Liangying Gan, MD — Renal Division, Department of Medicine, Peking University People's Hospital
• Study coordinator: Liangying Gan, MD
• Email: ganl@bjmu.edu.cn
• Phone: 010-88324516

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.