Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease
12 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Liangying Gan, MD
- Numéro de téléphone: 010-88324516
- E-mail: ganl@bjmu.edu.cn
Lieux d'étude
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Beijing, Chine
- Recrutement
- Peking University People's Hospital
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Contact:
- Liangying Gan, MD
- Numéro de téléphone: 010-88324516
- E-mail: ganl@bjmu.edu.cn
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Serum Indoxyl Sulfate (IS) Level Over Time
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Liangying Gan, MD, Renal Division, Department of Medicine, Peking University People's Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
21 avril 2025
Achèvement primaire (Estimé)
1 juillet 2026
Achèvement de l'étude (Estimé)
1 août 2026
Dates d'inscription aux études
Première soumission
23 mai 2026
Première soumission répondant aux critères de contrôle qualité
12 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2025PHB032-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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