Fecal Microbiota Transplantation for Refractory IgA Nephropathy

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: IgA Nephropathy

Treatments: Biological: Fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03633864

FMT for IgAN

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

FMT treatment

Experimental group

Description:

FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.

Treatment:

Biological: Fecal microbiota transplantation