Fecal Microbiota Transplantation for Refractory IgA Nephropathy

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

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.

Study Overview

• Status: Unknown
• Conditions: IgA Nephropathy
• Intervention / Treatment: Biological: Fecal microbiota transplantation

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiren Sun, M.D.; Phone Number: +8602984775193; Email: sunshiren@medmail.com.cn
• Study Contact Backup: Name: Ming Bai, M.D; Phone Number: +8602984775193; Email: mingbai1983@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Nephrology
      • Contact: Shiren Sun, M.D.; Phone Number: +8602984775193; Email: sunshiren@medmail.com.cn
      • Principal Investigator: Shiren Sun, M.D.
      • Contact: Ming Bai, M.D.; Phone Number: +8602984775193; Email: mingbai1983@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT treatment; FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Shiren Sun, M.D., Xijing Hospital, the Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 18, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: fecal microbiota transplantation; IgA nephropathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: FMT for IgAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No