End Stage Renal Disease on DialysisNCT07653711
Coated Aldehyde Oxystarch for Protein-Bound Uremic Toxin Reduction in End-Stage Renal Disease
A study testing Coated Aldehyde Oxystarch in people with End Stage Renal Disease on Dialysis, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Coated Aldehyde Oxystarch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Liangying Gan, MD, 010-88324516, ganl@bjmu.edu.cn
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Coated Aldehyde Oxystarch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated Aldehyde OxystarchDrug
Also called Xiqing
Each capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Coated Aldehyde Oxystarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: Baseline, Month 3
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start21 Apr 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangying Gan, MD, Peking University People's Hospital
- Investigators
- Liangying Gan, MD, Principal investigator, Renal Division, Department of Medicine, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653711
- Sponsor's protocol ID
- 2025PHB032-001
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Single-Center, Self-Controlled Trial of Coated Aldehyde Oxystarch for Reducing Protein-Bound Uremic Toxins in Patients With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT07653711
- Acronym / sponsor ID
- 2025PHB032-001
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Coated Aldehyde Oxystarch (Xiqing) | Experimental | Drug: Coated Aldehyde OxystarchParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coated Aldehyde OxystarchAlso: XiqingEach capsule contains 0.625g of Coated Aldehyde Oxystarch. Participants will take 10 capsules per time, three times daily for 3 months. | Drug | Experimental: Coated Aldehyde Oxystarch (Xiqing) |
Primary outcome
Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
Time frame: Baseline, 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.
Percentage Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3
Time frame: Baseline, 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%.
6 secondary outcomes
Change in Serum Indoxyl Sulfate (IS) Level Over Time
Time frame: Baseline, Month 1, Month 2, Month 3
Changes in Serum Phosphorus Levels
Time frame: Baseline, Month 1, Month 2, Month 3
Changes in Serum Calcium Levels
Time frame: Baseline, Month 1, Month 2, Month 3
Changes in Serum Potassium Levels
Time frame: Baseline, Month 1, Month 2, Month 3
Change in High-Sensitivity C-Reactive Protein (hs-CRP) Level
Time frame: Baseline, Month 1, Month 2, Month 3
Change From Baseline in Worst Itch Numeric Rating Scale Score Over Time
Time frame: Baseline, Month 1, Month 2, Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liangying Gan, MD principal investigator
Renal Division, Department of Medicine, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coated Aldehyde Oxystarch in people with End Stage Renal Disease on Dialysis, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liangying Gan, MD (010-88324516, ganl@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change From Baseline in Serum Indoxyl Sulfate (IS) Level at Month 3 (time frame: Baseline, Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.