IgA Nephropathy
Conditions
Keywords
IgA nephropathy, fecal microbiota transplantation
Brief 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. 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.
Interventions
BIOLOGICALFecal microbiota transplantation
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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Urinary protein | one time per week up to 8 weeks | 24 hours urinary protein quantity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of eGFR | one time per week up to 8 weeks | eGFR |
| Change of Hematuria | one time per week up to 8 weeks | Hematuria |
| Change of Blood pressure | one time per week up to 8 weeks | Blood pressure |
| Change of Serum creatinine | one time per week up to 8 weeks | Concentration of serum creatinine |
| Change of Fecal microbiota | one time per week up to 8 weeks | Fecal microbiota |
| Adverse events associated with FMT | one time per week up to 8 weeks | Adverse events associated with FMT |
| Change of Serum IgA1 | one time per week up to 8 weeks | Serum IgA1 |
Countries
China
Contacts
Primary ContactShiren Sun, M.D.
Backup ContactMing Bai, M.D
Outcome results
None listed