Clinical trial NCT03633864: Fecal Microbiota Transplantation for Refractory IgA Nephropathy
Official title: Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: IgA Nephropathy
Keywords: IgA nephropathy
fecal microbiota transplantation
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of Urinary protein
timeFrame: one time per week up to 8 weeks
Secondary outcomes:
measure: Change of Serum creatinine
timeFrame: one time per week up to 8 weeks
measure: Change of eGFR
timeFrame: one time per week up to 8 weeks
measure: Change of Hematuria
timeFrame: one time per week up to 8 weeks
measure: Change of Blood pressure
timeFrame: one time per week up to 8 weeks
measure: Change of Serum IgA1
timeFrame: one time per week up to 8 weeks
measure: Change of Fecal microbiota
timeFrame: one time per week up to 8 weeks
measure: Adverse events associated with FMT
timeFrame: one time per week up to 8 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Nephrology
state: Shaanxi
Study officials:
affiliation: Xijing Hospital, the Fourth Military Medical University
name: Shiren Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: