NCT07653711 Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease
| NCT ID | NCT07653711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | End Stage Renal Disease on Dialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-21 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-21 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Liangying Gan, MD
PRINCIPAL INVESTIGATOR
Renal Division, Department of Medicine, Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07653711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Renal Disease on Dialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07653711 currently recruiting?
Yes, NCT07653711 is actively recruiting participants. Contact the research team at ganl@bjmu.edu.cn for enrollment information.
Where is the NCT07653711 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07653711 clinical trial?
NCT07653711 is sponsored by Peking University People's Hospital. The principal investigator is Liangying Gan, MD at Renal Division, Department of Medicine, Peking University People's Hospital. The trial plans to enroll 30 participants.