RecruitingNot Applicable

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

China30 participantsStarted 2025-04-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 m…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is listed as Phase NA, meaning it's not a standard numbered drug trial phase, what does that mean for what we already know — or don't know — about the safety and effectiveness of Coated Aldehyde Oxystarch in people on dialysis?
2The trial is focused on reducing indoxyl sulfate, a protein-bound uremic toxin — how significant is my current indoxyl sulfate level, and is reducing it likely to matter for my specific health situation?
3This trial runs for at least 3 months of active measurement — given everything else I'm managing with end-stage renal disease and dialysis, is the time commitment and monitoring involved realistic for me right now?
4Are there any existing standard treatments or dietary approaches already shown to lower protein-bound uremic toxins like indoxyl sulfate that I should consider before or instead of joining a study like this?
5Since this is an actively recruiting trial, what would the enrollment process look like for me, and are there aspects of my current dialysis regimen or medications that might affect whether my doctor thinks it's worth exploring?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3

Timeframe: Baseline, Month 3

Percentage Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3

Timeframe: Baseline, Month 3

Trial details

NCT IDNCT07653711

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Liangying Gan, MD

010-88324516 ganl@bjmu.edu.cn

View on ClinicalTrials.gov More End Stage Renal Disease on Dialysis trials