Fecal Microbiota Transplantation for Refractory IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633864
• Other study ID #: FMT for IgAN
• Status: Recruiting
• Phase: Phase 2
• Start date: November 22, 2017
• Est. completion date: December 2020

Study information

• Verified date: August 2018
• Source: Fourth Military Medical University
• Contact: Shiren Sun, M.D.
• Phone: +8602984775193
• Email: sunshiren[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Biological:
• Fecal 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.

Locations

Country	Name	City	State
China	Xijing Hospital of Nephrology	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Urinary protein	24 hours urinary protein quantity	one time per week up to 8 weeks
Secondary	Change of Serum creatinine	Concentration of serum creatinine	one time per week up to 8 weeks
Secondary	Change of eGFR	eGFR	one time per week up to 8 weeks
Secondary	Change of Hematuria	Hematuria	one time per week up to 8 weeks
Secondary	Change of Blood pressure	Blood pressure	one time per week up to 8 weeks
Secondary	Change of Serum IgA1	Serum IgA1	one time per week up to 8 weeks
Secondary	Change of Fecal microbiota	Fecal microbiota	one time per week up to 8 weeks
Secondary	Adverse events associated with FMT	Adverse events associated with FMT	one time per week up to 8 weeks