Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease
2026年6月12日 更新者：Liangying Gan, MD、Peking University People's Hospital
An Exploratory, Single-Center, Self-Controlled Trial of Coated Aldehyde Oxystarch for Reducing Protein-Bound Uremic Toxins in Patients With End-Stage Renal Disease
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Liangying Gan, MD
- 电话号码：010-88324516
- 邮箱：ganl@bjmu.edu.cn
学习地点
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-
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Beijing、中国
- 招聘中
- Peking University People's Hospital
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接触：
- Liangying Gan, MD
- 电话号码：010-88324516
- 邮箱：ganl@bjmu.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental: Coated Aldehyde Oxystarch (Xiqing)
Participants with end-stage renal disease (ESRD) will receive Coated Aldehyde Oxystarch (Xiqing) orally at a dose of 10 capsules (0.625g/capsule) three times daily for 3 months.
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Each capsule contains 0.625g of Coated Aldehyde Oxystarch.
Participants will take 10 capsules per time, three times daily for 3 months.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
大体时间：Baseline, Month 3
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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.
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Baseline, Month 3
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Percentage Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
大体时间：Baseline, Month 3
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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%.
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Baseline, Month 3
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Serum Indoxyl Sulfate (IS) Level Over Time
大体时间：Baseline, Month 1, Month 2, Month 3
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Change from baseline in serum IS level at Month 1 and Month 2, in addition to Month 3. The trend of changes over different time points will be analyzed.
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Baseline, Month 1, Month 2, Month 3
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Changes in Serum Phosphorus Levels
大体时间：Baseline, Month 1, Month 2, Month 3
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Change from baseline in serum phosphorus levels at Month 1, Month 2, and Month 3.
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Baseline, Month 1, Month 2, Month 3
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Changes in Serum Calcium Levels
大体时间：Baseline, Month 1, Month 2, Month 3
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Change from baseline in serum calcium levels at Month 1, Month 2, and Month 3.
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Baseline, Month 1, Month 2, Month 3
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Changes in Serum Potassium Levels
大体时间：Baseline, Month 1, Month 2, Month 3
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Change from baseline in serum potassium levels at Month 1, Month 2, and Month 3.
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Baseline, Month 1, Month 2, Month 3
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Change in High-Sensitivity C-Reactive Protein (hs-CRP) Level
大体时间：Baseline, Month 1, Month 2, Month 3
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Change from baseline in serum hs-CRP level at Month 1, Month 2, and Month 3.
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Baseline, Month 1, Month 2, Month 3
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Change From Baseline in Worst Itch Numeric Rating Scale Score Over Time
大体时间：Baseline, Month 1, Month 2, Month 3
|
The change from baseline in pruritus severity associated with chronic kidney disease will be assessed using the Worst Itch Numeric Rating Scale at Month 1, Month 2, and Month 3. The Worst Itch Numeric Rating Scale ranges from 0 to 10, where 0 indicates no itch and 10 indicates the worst imaginable itch.
Higher scores indicate more severe pruritus.
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Baseline, Month 1, Month 2, Month 3
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Liangying Gan, MD、Renal Division, Department of Medicine, Peking University People's Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年4月21日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2026年8月1日
研究注册日期
首次提交
2026年5月23日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 2025PHB032-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.