NCT03633864

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

August 7, 2018

Last Update Submit

August 18, 2018

Conditions

IgA Nephropathy

Keywords

IgA nephropathyfecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

  • Change of Urinary protein

    24 hours urinary protein quantity

    one time per week up to 8 weeks

Secondary Outcomes (7)

  • Change of Serum creatinine

    one time per week up to 8 weeks

  • Change of eGFR

    one time per week up to 8 weeks

  • Change of Hematuria

    one time per week up to 8 weeks

  • Change of Blood pressure

    one time per week up to 8 weeks

  • Change of Serum IgA1

    one time per week up to 8 weeks

  • +2 more secondary outcomes

Study Arms (1)

FMT treatment

EXPERIMENTAL

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

Biological: Fecal microbiota transplantation

Interventions

Fecal microbiota transplantationBIOLOGICAL

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.

FMT treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital of Nephrology

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Shiren Sun, M.D.

    Xijing Hospital, the Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiren Sun, M.D.

CONTACT

+8602984775193sunshiren@medmail.com.cn

Ming Bai, M.D

CONTACT

+8602984775193mingbai1983@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 16, 2018

Study Start

November 22, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

CN(1)