Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease
12 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Liangying Gan, MD
- Número de teléfono: 010-88324516
- Correo electrónico: ganl@bjmu.edu.cn
Ubicaciones de estudio
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Beijing, Porcelana
- Reclutamiento
- Peking University People's Hospital
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Contacto:
- Liangying Gan, MD
- Número de teléfono: 010-88324516
- Correo electrónico: ganl@bjmu.edu.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Serum Indoxyl Sulfate (IS) Level Over Time
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Month 1, Month 2, Month 3
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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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Liangying Gan, MD, Renal Division, Department of Medicine, Peking University People's Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
21 de abril de 2025
Finalización primaria (Estimado)
1 de julio de 2026
Finalización del estudio (Estimado)
1 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
23 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2025PHB032-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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