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Fecal Microbiota Transplantation for Refractory IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT03633864
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shiren sun, Fourth Military Medical University

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE November 22, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
Change of Urinary protein [ Time Frame: one time per week up to 8 weeks ]
24 hours urinary protein quantity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03633864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Change of Serum creatinine [ Time Frame: one time per week up to 8 weeks ]
    Concentration of serum creatinine
  • Change of eGFR [ Time Frame: one time per week up to 8 weeks ]
    eGFR
  • Change of Hematuria [ Time Frame: one time per week up to 8 weeks ]
    Hematuria
  • Change of Blood pressure [ Time Frame: one time per week up to 8 weeks ]
    Blood pressure
  • Change of Serum IgA1 [ Time Frame: one time per week up to 8 weeks ]
    Serum IgA1
  • Change of Fecal microbiota [ Time Frame: one time per week up to 8 weeks ]
    Fecal microbiota
  • Adverse events associated with FMT [ Time Frame: one time per week up to 8 weeks ]
    Adverse events associated with FMT
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Microbiota Transplantation for Refractory IgA Nephropathy
Official Title  ICMJE Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE IgA Nephropathy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: FMT treatment
FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.
Intervention: Biological: Fecal microbiota transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 14, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shiren Sun, M.D. +8602984775193 sunshiren@medmail.com.cn
Contact: Ming Bai, M.D +8602984775193 mingbai1983@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03633864
Other Study ID Numbers  ICMJE FMT for IgAN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shiren sun, Fourth Military Medical University
Study Sponsor  ICMJE Fourth Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shiren Sun, M.D. Xijing Hospital, the Fourth Military Medical University
PRS Account Fourth Military Medical University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP