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

NCT07653711 | Recruiting

• 1 other identifier: 2025PHB032-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease on Dialysis

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline, Month 3

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

  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%.

  Baseline, Month 3

Secondary Outcomes (6)

• Change in Serum Indoxyl Sulfate (IS) Level Over Time

  Baseline, Month 1, Month 2, Month 3

• Changes in Serum Phosphorus Levels

  Baseline, Month 1, Month 2, Month 3

• Changes in Serum Calcium Levels

  Baseline, Month 1, Month 2, Month 3

• Changes in Serum Potassium Levels

  Baseline, Month 1, Month 2, Month 3

• Change in High-Sensitivity C-Reactive Protein (hs-CRP) Level

  Baseline, Month 1, Month 2, Month 3

Study Arms (1)

Experimental: Coated Aldehyde Oxystarch (Xiqing)

EXPERIMENTAL

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.

Drug: Coated Aldehyde Oxystarch

Interventions

Coated Aldehyde Oxystarch DRUG

Each capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months.

Also known as: Xiqing

Experimental: Coated Aldehyde Oxystarch (Xiqing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Study Officials

• Liangying Gan, MD

  Renal Division, Department of Medicine, Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangying Gan, MD

CONTACT

010-88324516; ganl@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 17, 2026
• Study Start: April 21, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)