Fecal Microbiota Transplantation for Refractory IgA Nephr... | NCT03633864

Studies
Fecal Microbiota Transplantation for Refractory IgA Nephropathy

NCT03633864

Sponsor

Air Force Military Medical University, China

Status

Unknown status

Last Update Posted

Aug 21, 2018Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

IgA Nephropathy

Interventions

Fecal microbiota transplantation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2017Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Aug 7, 2018

First Submission Date that Met QC Criteria

Aug 14, 2018

First Posted Date

Aug 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2018

Last Update Posted Date

Aug 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMT treatment	Experimental	FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.	Biological: Fecal microbiota transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fecal microbiota transplantation	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Urinary protein	24 hours urinary protein quantity	one time per week up to 8 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shiren Sun, M.D.	Contact	+8602984775193		sunshiren@medmail.com.cn
Ming Bai, M.D	Contact	+8602984775193		mingbai1983@126.com

Overall Officials

Name	Affiliation	Role
Shiren Sun, M.D.	Xijing Hospital, the Fourth Military Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital of Nephrology	Recruiting	Xi'an	Shaanxi	710032	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D001691	Biological Therapy
D013812	Therapeutics