Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKDNCT05543291
Multi-omics Analysis of Chronic Kidney Disease
An observational study of Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Chronic kidney disease (CKD) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD
- What is being tested?
- renal function
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion Criteria: 1. Confirmed CKD patients. 2. Age≥18 years. Exclusion criteria： 1. Age<18 years. 2. Patients with active gastrointestinal diseases, liver cirrhosis, cancer, active infection or cardiovascular event in the past 3 months, pregnancy or received renal replacement therapy.
Who may be able to join
- Age-matched and gender-matched HC with normal renal and liver function and not taking any medications were enrolled
Who cannot join
- Age<18 years.
- Individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy.
- Individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nephrolgoy, Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
Ai Peng, Ph.D., M.D., 86-21-66302524, pengai@hotmail.com
About this study
Chronic kidney disease (CKD) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.
- Being tested
- renal function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal functionBehavioural
levels of eGFR
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | Not described Receives: Behavioral: renal function | |
| mild CKD | Not described Receives: Behavioral: renal function | |
| Moderate CKD | Not described Receives: Behavioral: renal function | |
| ESRD | Not described Receives: Behavioral: renal function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism
Gut metagenome, fecal metabolome and serum metabolome were performed in this disease-severity classified CKD cohort, to identify the changes of microbial compositions and metabolism in CKD progression
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ai Peng, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543291
- Sponsor's protocol ID
- SHYS-IEC-5.0/22K162/P01
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang H, Xue W, Cheng J, He Y, Song Y, Hu D, Peng A, Li C, Bao H. Altered fecal microbial and metabolic profiles reveal potential mechanisms underlying anemia in patients with chronic renal failure. Microbiol Spectr. 2025 Aug 5;13(8):e0316624. doi: 10.1128/spectrum.03166-24. Epub 2025 Jun 17.
PubMed 40525868
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Analysis of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05543291
- Acronym / sponsor ID
- SHYS-IEC-5.0/22K162/P01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Sep 2022 (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) is a progressive disease with hidden epidemics and one of the most significant contributing factors to end-stage renal disease (ESRD), cardiovascular comorbidities, cachexia and anemia, which accounts for a nearly 1.2 million populations died per year.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy controls | – | Behavioral: renal function |
| mild CKD | – | Behavioral: renal function |
| Moderate CKD | – | Behavioral: renal function |
| ESRD | – | Behavioral: renal function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: 1. Confirmed CKD patients. 2. Age≥18 years. Exclusion criteria： 1. Age<18 years. 2. Patients with active gastrointestinal diseases, liver cirrhosis, cancer, active infection or cardiovascular event in the past 3 months, pregnancy or received renal replacement therapy.
Key inclusion criteria (1 listed)
- Age-matched and gender-matched HC with normal renal and liver function and not taking any medications were enrolled
Key exclusion criteria (3 listed)
- Age<18 years.
- Individuals with hypertension, diabetes, obesity, metabolic syndrome or pregnancy.
- Individuals who received gastrointestinal operation, antibiotics or probiotic products within one month.
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 |
|---|---|---|
| renal functionlevels of eGFR | Behavioural | ESRD, Moderate CKD, healthy controls, mild CKD |
Primary outcome
Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism
Time frame: baseline
Gut metagenome, fecal metabolome and serum metabolome were performed in this disease-severity classified CKD cohort, to identify the changes of microbial compositions and metabolism in CKD progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Derived from this study: PubMed 40525868Wang H, Xue W, Cheng J, He Y, Song Y, Hu D, Peng A, Li C, Bao H. Altered fecal microbial and metabolic profiles reveal potential mechanisms underlying anemia in patients with chronic renal failure. Microbiol Spectr. 2025 Aug 5;13(8):e0316624. doi: 10.1128/spectrum.03166-24. Epub 2025 Jun 17.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Potential Mechanisms Underlying the Microbiota-Gut-Kidney Axis in CKD, run by Shanghai 10th 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haichao Wang (15316167902, whctidy@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional and structural alteration of microbiotas and their crosstalk with CKD-associated metabolism (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05543291, which also lists 1 linked publication.
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 16 Sep 2022.