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

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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Drug: Coated Aldehyde Oxystarch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liangying Gan, MD; Phone Number: 010-88324516; Email: ganl@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Liangying Gan, MD; Phone Number: 010-88324516; Email: ganl@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Coated Aldehyde Oxystarch; Each capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months.; Other Names: Xiqing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Indoxyl Sulfate (IS) Level Over Time	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.	Baseline, Month 1, Month 2, Month 3
Changes in Serum Phosphorus Levels	Change from baseline in serum phosphorus levels at Month 1, Month 2, and Month 3.	Baseline, Month 1, Month 2, Month 3
Changes in Serum Calcium Levels	Change from baseline in serum calcium levels at Month 1, Month 2, and Month 3.	Baseline, Month 1, Month 2, Month 3
Changes in Serum Potassium Levels	Change from baseline in serum potassium levels at Month 1, Month 2, and Month 3.	Baseline, Month 1, Month 2, Month 3
Change in High-Sensitivity C-Reactive Protein (hs-CRP) Level	Change from baseline in serum hs-CRP level at Month 1, Month 2, and Month 3.	Baseline, Month 1, Month 2, Month 3
Change From Baseline in Worst Itch Numeric Rating Scale Score Over Time	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.	Baseline, Month 1, Month 2, Month 3

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Liangying Gan, MD, Renal Division, Department of Medicine, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 23, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025PHB032-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No