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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Coated Aldehyde Oxystarch

Treatment groups

30 Participants
are divided into 1 treatment group