Fecal Microbiota Transplantation for Refractory IgA Nephropathy

Study Overview
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Brief Summary
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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.

Official Title
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Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Biological: Fecal microbiota transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT treatment<br>FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy. | Biological: Fecal microbiota transplantation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Urinary protein | 24 hours urinary protein quantity | one time per week up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Serum creatinine | Concentration of serum creatinine | one time per week up to 8 weeks | 
| Change of eGFR | eGFR | one time per week up to 8 weeks | 
| Change of Hematuria | Hematuria | one time per week up to 8 weeks | 
| Change of Blood pressure | Blood pressure | one time per week up to 8 weeks | 
| Change of Serum IgA1 | Serum IgA1 | one time per week up to 8 weeks | 
| Change of Fecal microbiota | Fecal microbiota | one time per week up to 8 weeks | 
| Adverse events associated with FMT | Adverse events associated with FMT | one time per week up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgA nephropathy, fecal microbiota transplantation