CKDNCT05838118
Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)
A study testing Fecal Microbiota Transplantation in people with CKD, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Wahsed microbiota transplantation (WMT) is a novel and promising therapeutic method for Chronic Kidney Disease (CKD). This clinical trail aims to evaluate the efficacy and safety of WMT in the treatment of CKD. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- CKD
- What is being tested?
- Fecal Microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being diagnosed with chronic kidney disease without WMT in the past three months
- Able to tolerate colonoscopy
- Receiving rescue FMT from the China Microbiota Transplantation System
- Suitable and compatible with WMT treatment
- Patients who can fully understand the content of informed consent for this trial and voluntarily sign a written informed consent form
- Able to receive follow-up examinations, follow-up examinations and retain specimens on time
Who cannot join
- Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT
- Antibiotics or probiotics within 4 weeks prior to enrollment
- Patients with anxiety, depression, mental or legal disabilities
- Patients with fulminant type, massive bloody stools, and severe illness unable to tolerate colonoscopy
- Other patients deemed unsuitable for enrollment by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, 02556662092, fzhang@njmu.edu.cn
About this study
Official title: Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial
Wahsed microbiota transplantation (WMT) is a novel and promising therapeutic method for Chronic Kidney Disease (CKD). This clinical trail aims to evaluate the efficacy and safety of WMT in the treatment of CKD.
Read the detailed description
Although the therapeutic methods progress, numerous patients with Chronic Kidney Disease (CKD) can not avoid the clinical outcome of end-stage renal disease. CKD still needs novel treatment to significantly improve the survival quality of the patients.
Gut microbiota has been verified to have relation with immunity. Immunity plays a role in many chronic kidney disease, such as IgA nephropathy, membranous nephropathy and so on. Fecal microbiota transplantation (FMT) is a novel, safe, convenient therapeutic treatment which transplant gut microbiota from donor to patient to rebuild a gut microecology.
This study aims to evaluate the efficacy and safety of FMT in CKD patients. Patients in this study will undergo three times WMT. The primary outcome measure was the clinical remission efficacy rate in the CKD patients. The secondary outcome measure was the safety of WMT in CKD.
- Conditions
- CKD
- Being tested
- Fecal Microbiota Transplantation, Standard of Care for Chronic Kidney Disease
- Keywords
- Fecal Microbiota Transplantation (FMT), Chronic Kidney Disease (CKD)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationDrug
Biologically active human fecal fluid (donor stool) is provided in fluid form.
Standard of Care for Chronic Kidney DiseaseOther
Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.
| Study group | Role | What they receive |
|---|---|---|
| Washed Microbiota Transplantation to treat Chronic Kidney Disease | Other | Not described Receives: Drug: Fecal Microbiota Transplantation |
| Standard of Care for Chronic Kidney Disease | Other | Not described Receives: Other: Standard of Care for Chronic Kidney Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Blood Creatinine
Patients' Laboratory Change from Baseline Blood Creatinine
Measured: 1 week, 4 week, 12 week
Changes in 24-hour Urine Protein
Patients' Laboratory Change from Changes in 24-hour urine protein
Measured: 1 week, 4 week, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start20 Apr 2023 (estimated)
- 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 (4)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838118
- Sponsor's protocol ID
- FamingZhang
- Status last verified
- Jan 2023
- First submitted
- 8 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu H, Cao C, Wu Z, Zhang H, Sun Z, Wang M, Xu H, Zhao Z, Wang Y, Pei G, Yang Q, Zhu F, Yang J, Deng X, Hong Y, Li Y, Sun J, Zhu F, Shi M, Qian K, Ye T, Zuo X, Zhao F, Guo J, Xu G, Yao Y, Zeng R. The probiotic L. casei Zhang slows the progression of acute and chronic kidney disease. Cell Metab. 2021 Oct 5;33(10):2091-2093. doi: 10.1016/j.cmet.2021.08.015. No abstract available.
PubMed 34614411Xu KY, Xia GH, Lu JQ, Chen MX, Zhen X, Wang S, You C, Nie J, Zhou HW, Yin J. Impaired renal function and dysbiosis of gut microbiota contribute to increased trimethylamine-N-oxide in chronic kidney disease patients. Sci Rep. 2017 May 3;7(1):1445. doi: 10.1038/s41598-017-01387-y.
PubMed 28469156Xu L, Guo J, Moledina DG, Cantley LG. Immune-mediated tubule atrophy promotes acute kidney injury to chronic kidney disease transition. Nat Commun. 2022 Aug 19;13(1):4892. doi: 10.1038/s41467-022-32634-0.
PubMed 35986026Lu J, Chen PP, Zhang JX, Li XQ, Wang GH, Yuan BY, Huang SJ, Liu XQ, Jiang TT, Wang MY, Liu WT, Ruan XZ, Liu BC, Ma KL. GPR43 deficiency protects against podocyte insulin resistance in diabetic nephropathy through the restoration of AMPKalpha activity. Theranostics. 2021 Mar 4;11(10):4728-4742. doi: 10.7150/thno.56598. eCollection 2021.
PubMed 33754024
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial
- ClinicalTrials.gov ID
- NCT05838118
- Acronym / sponsor ID
- FamingZhang
- Conditions
- CKD
- Keywords
- Fecal Microbiota Transplantation (FMT), Chronic Kidney Disease (CKD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 May 2023 (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.
Wahsed microbiota transplantation (WMT) is a novel and promising therapeutic method for Chronic Kidney Disease (CKD). This clinical trail aims to evaluate the efficacy and safety of WMT in the treatment of CKD.
Detailed description
Although the therapeutic methods progress, numerous patients with Chronic Kidney Disease (CKD) can not avoid the clinical outcome of end-stage renal disease. CKD still needs novel treatment to significantly improve the survival quality of the patients.
Gut microbiota has been verified to have relation with immunity. Immunity plays a role in many chronic kidney disease, such as IgA nephropathy, membranous nephropathy and so on. Fecal microbiota transplantation (FMT) is a novel, safe, convenient therapeutic treatment which transplant gut microbiota from donor to patient to rebuild a gut microecology.
This study aims to evaluate the efficacy and safety of FMT in CKD patients. Patients in this study will undergo three times WMT. The primary outcome measure was the clinical remission efficacy rate in the CKD patients. The secondary outcome measure was the safety of WMT in CKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Washed Microbiota Transplantation to treat Chronic Kidney Disease | Other | Drug: Fecal Microbiota Transplantation |
| Standard of Care for Chronic Kidney Disease | Other | Other: Standard of Care for Chronic Kidney Disease |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Being diagnosed with chronic kidney disease without WMT in the past three months
- Able to tolerate colonoscopy
- Receiving rescue FMT from the China Microbiota Transplantation System
- Suitable and compatible with WMT treatment
- Patients who can fully understand the content of informed consent for this trial and voluntarily sign a written informed consent form
Key exclusion criteria (5 listed)
- Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT
- Antibiotics or probiotics within 4 weeks prior to enrollment
- Patients with anxiety, depression, mental or legal disabilities
- Patients with fulminant type, massive bloody stools, and severe illness unable to tolerate colonoscopy
- Other patients deemed unsuitable for enrollment by the investigator
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 |
|---|---|---|
| Fecal Microbiota TransplantationBiologically active human fecal fluid (donor stool) is provided in fluid form. | Drug | Washed Microbiota Transplantation to treat Chronic Kidney Disease |
| Standard of Care for Chronic Kidney DiseasePatients accepted oral drug or dialytic therapy like they used to be to treat CKD. | Other | Standard of Care for Chronic Kidney Disease |
Primary outcome
Changes in Blood Creatinine
Time frame: 1 week, 4 week, 12 week
Patients' Laboratory Change from Baseline Blood Creatinine
Changes in 24-hour Urine Protein
Time frame: 1 week, 4 week, 12 week
Patients' Laboratory Change from Changes in 24-hour urine protein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Results publication: PubMed 34614411Zhu H, Cao C, Wu Z, Zhang H, Sun Z, Wang M, Xu H, Zhao Z, Wang Y, Pei G, Yang Q, Zhu F, Yang J, Deng X, Hong Y, Li Y, Sun J, Zhu F, Shi M, Qian K, Ye T, Zuo X, Zhao F, Guo J, Xu G, Yao Y, Zeng R. The probiotic L. casei Zhang slows the progression of acute and chronic kidney disease. Cell Metab. 2021 Oct 5;33(10):2091-2093. doi: 10.1016/j.cmet.2021.08.015. No abstract available.
- Results publication: PubMed 28469156Xu KY, Xia GH, Lu JQ, Chen MX, Zhen X, Wang S, You C, Nie J, Zhou HW, Yin J. Impaired renal function and dysbiosis of gut microbiota contribute to increased trimethylamine-N-oxide in chronic kidney disease patients. Sci Rep. 2017 May 3;7(1):1445. doi: 10.1038/s41598-017-01387-y.
- Results publication: PubMed 35986026Xu L, Guo J, Moledina DG, Cantley LG. Immune-mediated tubule atrophy promotes acute kidney injury to chronic kidney disease transition. Nat Commun. 2022 Aug 19;13(1):4892. doi: 10.1038/s41467-022-32634-0.
- Results publication: PubMed 33754024Lu J, Chen PP, Zhang JX, Li XQ, Wang GH, Yuan BY, Huang SJ, Liu XQ, Jiang TT, Wang MY, Liu WT, Ruan XZ, Liu BC, Ma KL. GPR43 deficiency protects against podocyte insulin resistance in diabetic nephropathy through the restoration of AMPKalpha activity. Theranostics. 2021 Mar 4;11(10):4728-4742. doi: 10.7150/thno.56598. eCollection 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation in people with CKD, run by The Second Hospital of Nanjing Medical University 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 6 inclusion and 5 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 1 May 2023. 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 Faming Zhang (02556662092, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Creatinine (time frame: 1 week, 4 week, 12 week). 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?
On the ClinicalTrials.gov record for NCT05838118, which also lists 4 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 1 May 2023.