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Fecal Microbiota Transplantation for Refractory IgA Nephropathy

Primary Purpose

IgA Nephropathy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA nephropathy, fecal microbiota transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Xijing Hospital of NephrologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Change of Urinary protein
24 hours urinary protein quantity

Secondary Outcome Measures

Change of Serum creatinine
Concentration of serum creatinine
Change of eGFR
eGFR
Change of Hematuria
Hematuria
Change of Blood pressure
Blood pressure
Change of Serum IgA1
Serum IgA1
Change of Fecal microbiota
Fecal microbiota
Adverse events associated with FMT
Adverse events associated with FMT

Full Information

First Posted
August 7, 2018
Last Updated
August 18, 2018
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03633864
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 22, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
IgA nephropathy, fecal microbiota transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT treatment
Arm Type
Experimental
Arm Description
FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.
Intervention Type
Biological
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Urinary protein
Description
24 hours urinary protein quantity
Time Frame
one time per week up to 8 weeks
Secondary Outcome Measure Information:
Title
Change of Serum creatinine
Description
Concentration of serum creatinine
Time Frame
one time per week up to 8 weeks
Title
Change of eGFR
Description
eGFR
Time Frame
one time per week up to 8 weeks
Title
Change of Hematuria
Description
Hematuria
Time Frame
one time per week up to 8 weeks
Title
Change of Blood pressure
Description
Blood pressure
Time Frame
one time per week up to 8 weeks
Title
Change of Serum IgA1
Description
Serum IgA1
Time Frame
one time per week up to 8 weeks
Title
Change of Fecal microbiota
Description
Fecal microbiota
Time Frame
one time per week up to 8 weeks
Title
Adverse events associated with FMT
Description
Adverse events associated with FMT
Time Frame
one time per week up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiren Sun, M.D.
Phone
+8602984775193
Email
sunshiren@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Bai, M.D
Phone
+8602984775193
Email
mingbai1983@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.
Organizational Affiliation
Xijing Hospital, the Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Nephrology
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.
Phone
+8602984775193
Email
sunshiren@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Ming Bai, M.D.
Phone
+8602984775193
Email
mingbai1983@126.com
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Fecal Microbiota Transplantation for Refractory IgA Nephropathy

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