CKDPhase 4NCT07182942
The Effect and Mechanism of Xiqing Regulating Intestinal Homeostasis on Drug Efficacy of Chronic Kidney Disease
A Phase 4 study testing Xiqing and probiotics in people with CKD and Drug Effect, run by Chujin Cao at 1 site in China.
Trial summary
Chronic kidney disease (CKD) has become a major public health problem worldwide. Patients with CKD are often accompanied by azotemia due to impaired renal function and excretion of nitrogen metabolic waste, which leads to multiple organ dysfunction, cardiac dysfunction and other complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- CKD, Drug Effect
- What is being tested?
- Xiqing and probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2024to 31 Dec 2025
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent was obtained;
- ranging in age from 18 to 75 years;
- CKD stage 3-5, that is, eGFR < 60 mL/min/1.73 m2 with non-dialysis stage, no dialysis indication, temporarily stable condition and drug control stage;
- tolerance of Xiqing and probiotics treatment.
Who cannot join
- with severe active infection, influence of nutritional status in patients with malignant tumor and other diseases;
- patients during pregnancy or lactation;
- unstable vital signs, the condition is not stable, need dialysis patients;
- patients with intolerance of Xiqing;
- patients with intolerance of probiotics;
- taking corticosteroids, antibiotics or other immunosuppressive agents within the past 3 months;
- taking adsorbent drugs, such as medicinal charcoal tablets, within the past 3 months.
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
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Chujin Cao, PhD, +86 18202742892, ccj9501@163.com
About this study
Chronic kidney disease (CKD) has become a major public health problem worldwide. Patients with CKD are often accompanied by azotemia due to impaired renal function and excretion of nitrogen metabolic waste, which leads to multiple organ dysfunction, cardiac dysfunction and other complications. Therefore, it is an important strategy in the treatment of CKD to reduce the burden of kidney in CKD patients by removing nitrogen metabolic wastes in the body. Xiqing, which includes coated aldehyde oxystarch capsules, is a drug with adsorption effect. As an effective nitrogen metabolic waste adsorbent, it is widely used in the treatment of CKD patients. Gut is an important organ for the generation of nitrogen metabolic waste in the body. Intestinal homeostasis is an important regulator of nitrogen metabolism, and supplementation of probiotics is one of the main ways to regulate intestinal homeostasis. A study published by the team of investigators in the journal Cell Metabolism in 2021 confirmed that probiotics (Lactobacillus casei Zhang) reduced the BUN level in CKD mice, intestinal inflammation and the permeability of intestinal mucosal barrier, and delay the progression of CKD patients through animal experiments and clinical trials. So, whether the application of Xiqing changes intestinal homeostasis, including intestinal flora structure, function and function of intestinal mucosa, intestinal metabolites? Whether drug effect is affected by intestinal balance of CKD? What is the mechanism? Is Xiqing combined with probiotics more conducive to reducing BUN level and delaying the progression of CKD patients? The discussion of the problem and solution will help clinicians for the pioneering understanding of the use of Xiqing.
In this study, the investigators designed a prospective, randomized, open-label, blinded end-point clinical trial, using microbial diversity, metagenomics, targeted and non-targeted metabolomics detection and other technologies, through the joint analysis of multi-omics data, to explore the effect of the use of Xiqing on the intestinal homeostasis of CKD, and the extent of the drug efficacy of Xiqing is affected by the intestinal homeostasis of CKD. The effect of Xiqing combined the probiotics regulating intestinal homeostasis on CKD and the molecular mechanism, which provide more research references for the clinical application of Xiqing.
- Conditions
- CKD, Drug Effect
- Being tested
- Xiqing, probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XiqingDrug
oral intervention of Xiqing
probioticsDrug
oral intervention of probiotics
| Study group | Role | What they receive |
|---|---|---|
| CKD+Xiqing | Experimental | This group is experimental one, which is CKD patients with Xiqing intervention alone. Receives: Drug: Xiqing |
| CKD+Pro | Experimental | This group is experimental one, which is CKD patients with the probiotics intervention alone. Receives: Drug: probiotics |
| CKD+Xiqing+Pro | Experimental | This group is experimental one, which is CKD patients with the intervention of Xiqing combined the probiotics. Receives: Drug: Xiqing; Drug: probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney disease progression
Entry into end-stage renal disease or serum creatinine values doubled
Measured: 3 months
Secondary outcomes (1)
Cardiovascular events
Occurrence of cardiovascular events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start7 Jun 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chujin Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chujin Cao, Tongji Hospital
- Investigators
- Ying Yao, PhD, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182942
- Sponsor's protocol ID
- 103630
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanism of Xiqing Regulating Intestinal Homeostasis on Drug Efficacy of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07182942
- Acronym / sponsor ID
- 103630
- Conditions
- CKD, Drug Effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chujin CaoUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2025 (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.
Chronic kidney disease (CKD) has become a major public health problem worldwide. Patients with CKD are often accompanied by azotemia due to impaired renal function and excretion of nitrogen metabolic waste, which leads to multiple organ dysfunction, cardiac dysfunction and other complications. Therefore, it is an important strategy in the treatment of CKD to reduce the burden of kidney in CKD patients by removing nitrogen metabolic wastes in the body. Xiqing, which includes coated aldehyde oxystarch capsules, is a drug with adsorption effect. As an effective nitrogen metabolic waste adsorbent, it is widely used in the treatment of CKD patients. Gut is an important organ for the generation of nitrogen metabolic waste in the body. Intestinal homeostasis is an important regulator of nitrogen metabolism, and supplementation of probiotics is one of the main ways to regulate intestinal homeostasis. A study published by the team of investigators in the journal Cell Metabolism in 2021 confirmed that probiotics (Lactobacillus casei Zhang) reduced the BUN level in CKD mice, intestinal inflammation and the permeability of intestinal mucosal barrier, and delay the progression of CKD patients through animal experiments and clinical trials. So, whether the application of Xiqing changes intestinal homeostasis, including intestinal flora structure, function and function of intestinal mucosa, intestinal metabolites? Whether drug effect is affected by intestinal balance of CKD? What is the mechanism? Is Xiqing combined with probiotics more conducive to reducing BUN level and delaying the progression of CKD patients? The discussion of the problem and solution will help clinicians for the pioneering understanding of the use of Xiqing.
In this study, the investigators designed a prospective, randomized, open-label, blinded end-point clinical trial, using microbial diversity, metagenomics, targeted and non-targeted metabolomics detection and other technologies, through the joint analysis of multi-omics data, to explore the effect of the use of Xiqing on the intestinal homeostasis of CKD, and the extent of the drug efficacy of Xiqing is affected by the intestinal homeostasis of CKD. The effect of Xiqing combined the probiotics regulating intestinal homeostasis on CKD and the molecular mechanism, which provide more research references for the clinical application of Xiqing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD+Xiqing | Experimental | Drug: XiqingThis group is experimental one, which is CKD patients with Xiqing intervention alone. |
| CKD+Pro | Experimental | Drug: probioticsThis group is experimental one, which is CKD patients with the probiotics intervention alone. |
| CKD+Xiqing+Pro | Experimental | Drug: Xiqing, Drug: probioticsThis group is experimental one, which is CKD patients with the intervention of Xiqing combined the probiotics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent was obtained;
- ranging in age from 18 to 75 years;
- CKD stage 3-5, that is, eGFR < 60 mL/min/1.73 m2 with non-dialysis stage, no dialysis indication, temporarily stable condition and drug control stage;
- tolerance of Xiqing and probiotics treatment.
Key exclusion criteria (7 listed)
- with severe active infection, influence of nutritional status in patients with malignant tumor and other diseases;
- patients during pregnancy or lactation;
- unstable vital signs, the condition is not stable, need dialysis patients;
- patients with intolerance of Xiqing;
- patients with intolerance of probiotics;
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 |
|---|---|---|
| Xiqingoral intervention of Xiqing | Drug | CKD+Xiqing, CKD+Xiqing+Pro |
| probioticsoral intervention of probiotics | Drug | CKD+Pro, CKD+Xiqing+Pro |
Primary outcome
Kidney disease progression
Time frame: 3 months
Entry into end-stage renal disease or serum creatinine values doubled
1 secondary outcome
Cardiovascular events
Time frame: 3 months
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 19 Sep 2025.
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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.
Ying Yao, PhD study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiqing and probiotics in people with CKD and Drug Effect, run by Chujin Cao 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 7 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 19 Sep 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chujin Cao, PhD (+86 18202742892, ccj9501@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney disease progression (time frame: 3 months). 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 19 Sep 2025.