IgA NephropathyPhase 2NCT03633864
Fecal Microbiota Transplantation for Refractory IgA Nephropathy
A Phase 2 study testing Fecal microbiota transplantation in people with IgA Nephropathy, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
IgA nephropathy (IgAN) is one of the most common glomerular diseases worldwide. Current treatments for IgAN are limited by their relatively insufficient efficacy and severe adverse events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Fecal microbiota transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2017to Dec 2020
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, age: 18-65 years old.
- Pathological diagnosis with IgAN, eGFR：20-120 mL/min/1.73 m2.
- The 24-hour urinary protein was still greater than 1g after 3-6 months of treatment of ACEI/ARB
- Recurrence of IgAN after glucocorticoid and (or)immunosuppressant decrement and the 24-hour urinary protein was greater than 1g.
- Not suitable for the administration of glucocorticoid and (or) immunosuppressive agents because of side effects.
- Women of child-bearing age with negative urine pregnancy test have no pregnancy plan for the next 18 months and take effective contraceptive measures.
- Agree to participate in this clinical trial
Who cannot join
- Malignant tumors and other diseases with expected survival time <3 months.
- Severe cardiovascular and cerebrovascular diseases and pulmonary dysfunction.
- Other immune system diseases.
- Diabetes
- Inflammatory bowel disease（IBD）
- Clostridium difficile infection
Show all 15Show fewer
- Gastrointestinal tumor
- Active gastrointestinal bleeding
- Acute and chronic gastroenteritis
- Have received or are receiving FMT treatment.
- HIV
- Psychosis AND dysgnosia
- Contraindication of colonoscopy and enema
- Alcohol/drug abuse
- Other conditions that the researchers thought were not appropriate for the group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Nephrology
Xi'an, Shaanxi, 710032
Shiren Sun, M.D., +8602984775193, sunshiren@medmail.com.cn
Ming Bai, M.D., +8602984775193, mingbai1983@126.com
About this study
Official title: Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study
IgA nephropathy (IgAN) is one of the most common glomerular diseases worldwide. Current treatments for IgAN are limited by their relatively insufficient efficacy and severe adverse events. Previous studies suggested that the disorder of intestinal flora may play an important role in the pathogenesis and prognosis of IgAN. Fecal microbiota transplantation (FMT) have been proved to be effective on rebuilding the intestinal microecological balance. However, there is no evidence for the safety and efficacy of FMT in IgAN. Therefore, investigators perform a prospective cohort study to evaluate the safety and efficacy of FMT in IgAN patients who did not response to the conventional treatment and did not want to aggravate immunosuppressive treatments or IgAN patients who did not response to immunosuppressive treatments.
- Conditions
- IgA Nephropathy
- Being tested
- Fecal microbiota transplantation
- Keywords
- IgA nephropathy, fecal microbiota transplantation
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationBiological
Fecal donors are selected according to the predefined criteria. Fecal microbiota suspension is prepared by using fresh feces from the selected fecal donors. Then, administration of 200 ml fecal microbiota suspension through a transendoscopic enteral tubing or retention enema.
| Study group | Role | What they receive |
|---|---|---|
| FMT treatment | Experimental | FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy. Receives: Biological: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Urinary protein
24 hours urinary protein quantity
Measured: one time per week up to 8 weeks
Secondary outcomes (7)
Change of Serum creatinine
Concentration of serum creatinine
Measured: one time per week up to 8 weeks
Change of eGFR
eGFR
Measured: one time per week up to 8 weeks
Change of Hematuria
Hematuria
Measured: one time per week up to 8 weeks
Change of Blood pressure
Blood pressure
Measured: one time per week up to 8 weeks
Change of Serum IgA1
Serum IgA1
Measured: one time per week up to 8 weeks
Change of Fecal microbiota
Fecal microbiota
Measured: one time per week up to 8 weeks
Adverse events associated with FMT
Adverse events associated with FMT
Measured: one time per week up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start22 Nov 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
- Investigators
- Shiren Sun, M.D., Principal investigator, Xijing Hospital, the Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633864
- Sponsor's protocol ID
- FMT for IgAN
- Status last verified
- Aug 2018
- First submitted
- 7 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study
- ClinicalTrials.gov ID
- NCT03633864
- Acronym / sponsor ID
- FMT for IgAN
- Conditions
- IgA Nephropathy
- Keywords
- IgA nephropathy, fecal microbiota transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Aug 2018 (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.
IgA nephropathy (IgAN) is one of the most common glomerular diseases worldwide. Current treatments for IgAN are limited by their relatively insufficient efficacy and severe adverse events. Previous studies suggested that the disorder of intestinal flora may play an important role in the pathogenesis and prognosis of IgAN. Fecal microbiota transplantation (FMT) have been proved to be effective on rebuilding the intestinal microecological balance. However, there is no evidence for the safety and efficacy of FMT in IgAN. Therefore, investigators perform a prospective cohort study to evaluate the safety and efficacy of FMT in IgAN patients who did not response to the conventional treatment and did not want to aggravate immunosuppressive treatments or IgAN patients who did not response to immunosuppressive treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT treatment | Experimental | Biological: Fecal microbiota transplantationFMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult, age: 18-65 years old.
- Pathological diagnosis with IgAN, eGFR：20-120 mL/min/1.73 m2.
- The 24-hour urinary protein was still greater than 1g after 3-6 months of treatment of ACEI/ARB
- Recurrence of IgAN after glucocorticoid and (or)immunosuppressant decrement and the 24-hour urinary protein was greater than 1g.
- Not suitable for the administration of glucocorticoid and (or) immunosuppressive agents because of side effects.
Key exclusion criteria (15 listed)
- Malignant tumors and other diseases with expected survival time <3 months.
- Severe cardiovascular and cerebrovascular diseases and pulmonary dysfunction.
- Other immune system diseases.
- Diabetes
- Inflammatory bowel disease（IBD）
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 transplantationFecal donors are selected according to the predefined criteria. Fecal microbiota suspension is prepared by using fresh feces from the selected fecal donors. Then, administration of 200 ml fecal microbiota suspension through a transendoscopic enteral tubing or retention enema. | Biological | FMT treatment |
Primary outcome
Change of Urinary protein
Time frame: one time per week up to 8 weeks
24 hours urinary protein quantity
7 secondary outcomes
Change of Serum creatinine
Time frame: one time per week up to 8 weeks
Change of eGFR
Time frame: one time per week up to 8 weeks
Change of Hematuria
Time frame: one time per week up to 8 weeks
Change of Blood pressure
Time frame: one time per week up to 8 weeks
Change of Serum IgA1
Time frame: one time per week up to 8 weeks
Change of Fecal microbiota
Time frame: one time per week up to 8 weeks
Adverse events associated with FMT
Time frame: one time per week up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Shiren Sun, M.D. principal investigator
Xijing Hospital, the Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal microbiota transplantation in people with IgA Nephropathy, run by Air Force Military Medical University, China 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 7 inclusion and 15 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 21 Aug 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shiren Sun, M.D. (+8602984775193, sunshiren@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Urinary protein (time frame: one time per week up to 8 weeks). 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 21 Aug 2018.