Kidney Failure, ChronicNCT03010696
The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
An observational study of Kidney Failure, Chronic, run by China Agricultural University at 4 sites in China.
Trial summary
The purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Chronic
- How many people
- 293 participants
- Where
- 4 sitesChina
- Study dates
- Jun 2015to Dec 2017
- 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: Two hundred and twenty three ESRD patients with hemodialysis are recruited from Department of Nephrology of 4 hospitals. Seventy healthy subjects are also recruited to compare the microbiome/metabolite differences between two groups.
Who may be able to join
- Age over 18 years old
- Liver and kidney function is normal
- 18.5≤BMI≤29.9
- Agree to sign the informed consent form
- Age over 18 years old
- Patients who diagnosed as ESRD with hemodialysis
- Fixed hemodialysis cycle (average 3 times a week)
- Agree to sign the informed consent form
Who cannot join
- Diagnosed as Metabolic syndrome
- Diagnosed as Cirrhosis
- Diagnosed as kidney disease
- Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
- Taking antibiotics or antifungal drugs within 30 days before the study
- For ESRD patients
Show all 10Show fewer
- Taking antibiotics or antifungal drugs within 30 days before the study
- Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
- Reasercher are not sure whether the subjects are willing or able to complete the study
- Subject participated in other research projects within two months before the study
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Anzhen Hospital
Beijing, 100029
General Hospital of Chinese Armed Police Forces
Beijing, 100039
Peking University Aerospace Centre Hospital
Beijing, 100049
Peking University Shougang Hospital
Beijing, 100144
About this study
The purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.
- Conditions
- Kidney Failure, Chronic
- Being tested
- No interventions, questionnaire, collect specimen
- Keywords
- Kidney Failure, Chronic, Uremic toxins, Gastrointestinal Microbiome, Metabolomics
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions, questionnaire, collect specimenOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Normal kidney function Receives: Other: No interventions, questionnaire, collect specimen | |
| ESRD patients | Diagnosed as ESRD with hemodialysis Receives: Other: No interventions, questionnaire, collect specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota-derived uremic toxin
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Fecal Microbiome
Measured: Through study completion, an average of 1 year
Fecal metabolites
Measured: Through study completion, an average of 1 year
Blood metabolites
Measured: Through study completion, an average of 1 year
Complete blood count
Measured: Through study completion, an average of 1 year
Blood biochemistry test
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Agricultural University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Aerospace Center Hospital, General Hospital of Chinese Armed Police Forces, Beijing Anzhen Hospital, Peking University Shougang Hospital, Beijing Heyiyuan Biotech Co. Ltd., Shenzhen Microbiota Technology Co. Ltd.
- Responsible party
- Principal investigator, Fazheng Ren, China Agricultural University
- Investigators
- Fazheng Ren, PhD, Principal investigator, China Agricultural Universtiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010696
- Sponsor's protocol ID
- CAUPCKD-01
- Status last verified
- Oct 2020
- First submitted
- 28 Dec 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
PubMed 22992469Poesen R, Windey K, Neven E, Kuypers D, De Preter V, Augustijns P, D'Haese P, Evenepoel P, Verbeke K, Meijers B. The Influence of CKD on Colonic Microbial Metabolism. J Am Soc Nephrol. 2016 May;27(5):1389-99. doi: 10.1681/ASN.2015030279. Epub 2015 Sep 23.
PubMed 26400570Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.
PubMed 26376131Anders HJ, Andersen K, Stecher B. The intestinal microbiota, a leaky gut, and abnormal immunity in kidney disease. Kidney Int. 2013 Jun;83(6):1010-6. doi: 10.1038/ki.2012.440. Epub 2013 Jan 16.
PubMed 23325079Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.
PubMed 24231662Poesen R, Claes K, Evenepoel P, de Loor H, Augustijns P, Kuypers D, Meijers B. Microbiota-Derived Phenylacetylglutamine Associates with Overall Mortality and Cardiovascular Disease in Patients with CKD. J Am Soc Nephrol. 2016 Nov;27(11):3479-3487. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.
PubMed 27230658Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
PubMed 17898101Aronov PA, Luo FJ, Plummer NS, Quan Z, Holmes S, Hostetter TH, Meyer TW. Colonic contribution to uremic solutes. J Am Soc Nephrol. 2011 Sep;22(9):1769-76. doi: 10.1681/ASN.2010121220. Epub 2011 Jul 22.
PubMed 21784895Wang X, Yang S, Li S, Zhao L, Hao Y, Qin J, Zhang L, Zhang C, Bian W, Zuo L, Gao X, Zhu B, Lei XG, Gu Z, Cui W, Xu X, Li Z, Zhu B, Li Y, Chen S, Guo H, Zhang H, Sun J, Zhang M, Hui Y, Zhang X, Liu X, Sun B, Wang L, Qiu Q, Zhang Y, Li X, Liu W, Xue R, Wu H, Shao D, Li J, Zhou Y, Li S, Yang R, Pedersen OB, Yu Z, Ehrlich SD, Ren F. Aberrant gut microbiota alters host metabolome and impacts renal failure in humans and rodents. Gut. 2020 Dec;69(12):2131-2142. doi: 10.1136/gutjnl-2019-319766. Epub 2020 Apr 2.
PubMed 32241904
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Gut Microbiome/Metabolite and End Stage Renal Disease (ESRD)
- ClinicalTrials.gov ID
- NCT03010696
- Acronym / sponsor ID
- CAUPCKD-01
- Conditions
- Kidney Failure, Chronic
- Keywords
- Kidney Failure, Chronic, Uremic toxins, Gastrointestinal Microbiome, Metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- China Agricultural UniversityUniversity, hospital or other
- Collaborators
- Peking University Aerospace Center Hospital, General Hospital of Chinese Armed Police Forces, Beijing Anzhen Hospital, Peking University Shougang Hospital, Beijing Heyiyuan Biotech Co. Ltd., Shenzhen Microbiota Technology Co. Ltd.
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Jan 2017 (estimated)
- 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 purpose of this study is to investigate the differences of gut Microbiome/Metabolite between ESRD patients and healthy subjects. Two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: No interventions, questionnaire, collect specimenNormal kidney function |
| ESRD patients | – | Other: No interventions, questionnaire, collect specimenDiagnosed as ESRD with hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred and twenty three ESRD patients with hemodialysis are recruited from Department of Nephrology of 4 hospitals. Seventy healthy subjects are also recruited to compare the microbiome/metabolite differences between two groups.
Key inclusion criteria (8 listed)
- Age over 18 years old
- Liver and kidney function is normal
- 18.5≤BMI≤29.9
- Agree to sign the informed consent form
- Age over 18 years old
Key exclusion criteria (10 listed)
- Diagnosed as Metabolic syndrome
- Diagnosed as Cirrhosis
- Diagnosed as kidney disease
- Taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study
- Taking antibiotics or antifungal drugs within 30 days before the study
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 |
|---|---|---|
| No interventions, questionnaire, collect specimen | Other | ESRD patients, Healthy subjects |
Primary outcome
Microbiota-derived uremic toxin
Time frame: Through study completion, an average of 1 year
5 secondary outcomes
Fecal Microbiome
Time frame: Through study completion, an average of 1 year
Fecal metabolites
Time frame: Through study completion, an average of 1 year
Blood metabolites
Time frame: Through study completion, an average of 1 year
Complete blood count
Time frame: Through study completion, an average of 1 year
Blood biochemistry test
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 22992469Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
- Background: PubMed 26400570Poesen R, Windey K, Neven E, Kuypers D, De Preter V, Augustijns P, D'Haese P, Evenepoel P, Verbeke K, Meijers B. The Influence of CKD on Colonic Microbial Metabolism. J Am Soc Nephrol. 2016 May;27(5):1389-99. doi: 10.1681/ASN.2015030279. Epub 2015 Sep 23.
- Background: PubMed 26376131Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.
- Background: PubMed 23325079Anders HJ, Andersen K, Stecher B. The intestinal microbiota, a leaky gut, and abnormal immunity in kidney disease. Kidney Int. 2013 Jun;83(6):1010-6. doi: 10.1038/ki.2012.440. Epub 2013 Jan 16.
- Background: PubMed 24231662Ramezani A, Raj DS. The gut microbiome, kidney disease, and targeted interventions. J Am Soc Nephrol. 2014 Apr;25(4):657-70. doi: 10.1681/ASN.2013080905. Epub 2013 Nov 14.
- Background: PubMed 27230658Poesen R, Claes K, Evenepoel P, de Loor H, Augustijns P, Kuypers D, Meijers B. Microbiota-Derived Phenylacetylglutamine Associates with Overall Mortality and Cardiovascular Disease in Patients with CKD. J Am Soc Nephrol. 2016 Nov;27(11):3479-3487. doi: 10.1681/ASN.2015121302. Epub 2016 May 26.
- Background: PubMed 17898101Meyer TW, Hostetter TH. Uremia. N Engl J Med. 2007 Sep 27;357(13):1316-25. doi: 10.1056/NEJMra071313. No abstract available.
- Background: PubMed 21784895Aronov PA, Luo FJ, Plummer NS, Quan Z, Holmes S, Hostetter TH, Meyer TW. Colonic contribution to uremic solutes. J Am Soc Nephrol. 2011 Sep;22(9):1769-76. doi: 10.1681/ASN.2010121220. Epub 2011 Jul 22.
- Derived from this study: PubMed 32241904Wang X, Yang S, Li S, Zhao L, Hao Y, Qin J, Zhang L, Zhang C, Bian W, Zuo L, Gao X, Zhu B, Lei XG, Gu Z, Cui W, Xu X, Li Z, Zhu B, Li Y, Chen S, Guo H, Zhang H, Sun J, Zhang M, Hui Y, Zhang X, Liu X, Sun B, Wang L, Qiu Q, Zhang Y, Li X, Liu W, Xue R, Wu H, Shao D, Li J, Zhou Y, Li S, Yang R, Pedersen OB, Yu Z, Ehrlich SD, Ren F. Aberrant gut microbiota alters host metabolome and impacts renal failure in humans and rodents. Gut. 2020 Dec;69(12):2131-2142. doi: 10.1136/gutjnl-2019-319766. Epub 2020 Apr 2.
- 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. This study is not recruiting at the moment.
Fazheng Ren, PhD principal investigator
China Agricultural Universtiy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by China Agricultural University at 4 sites 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota-derived uremic toxin (time frame: Through study completion, an average of 1 year). 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 NCT03010696, which also lists 9 linked publications.
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 22 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.