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

Официальное название

An Exploratory, Single-Center, Self-Controlled Trial of Coated Aldehyde Oxystarch for Reducing Protein-Bound Uremic Toxins in Patients With End-Stage Renal Disease

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3 [Срок оценки: Baseline, Month 3]
• Percentage Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3 [Срок оценки: Baseline, Month 3]

Вторичные конечные точки (6)

• Change in Serum Indoxyl Sulfate (IS) Level Over Time [Срок оценки: Baseline, Month 1, Month 2, Month 3]
• Changes in Serum Phosphorus Levels [Срок оценки: Baseline, Month 1, Month 2, Month 3]
• Changes in Serum Calcium Levels [Срок оценки: Baseline, Month 1, Month 2, Month 3]
• Changes in Serum Potassium Levels [Срок оценки: Baseline, Month 1, Month 2, Month 3]
• Change in High-Sensitivity C-Reactive Protein (hs-CRP) Level [Срок оценки: Baseline, Month 1, Month 2, Month 3]
• Change From Baseline in Worst Itch Numeric Rating Scale Score Over Time [Срок оценки: Baseline, Month 1, Month 2, Month 3]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07653711 · 2025PHB032-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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