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Safety and efficacy of fecal microbiota transplantation in the treatment of idiopathic membranous nephropathy: a randomized controlled clinical trial

Safety and efficacy of fecal microbiota transplantation in the treatment of idiopathic membranous nephropathy: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083251
Enrollment
Unknown
Registered
2024-04-19
Start date
2024-04-25
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic membranous nephropathy

Interventions

Sponsors

The First Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: a)Age:18-70 years old; b)Pathologically diagnosed as idiopathic membranous nephropathy; c)Persistent of 24-hour urinary protein is more than 1g and less than 3.5g; d)eGFR>60 mL/min/1.73m2; e)Plan to give the patient supportive treatment, including angiotensin-converting enzyme inhibitors (ACEIs) and/or angiotensin-receptor blockers (ARBs); f)Agree to participate in this project and sign an informed consent form.

Exclusion criteria

Exclusion criteria: a)Patients have secondary membranous nephropathy from various causes (e.g., hepatitis B/C virus infection, lupus, malignancy, rheumatoid arthritis, drug and heavy metal poisoning); b)The patient had other co-existing kidney disease; c)The expected survival time of severe cardio-vascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors and other diseases is less than 3 months, combined with other autoimmune diseases, diabetes; d)Gastrointestinal active bleeding; e)Acute and chronic gastroenteritis; f)Have previously received or are undergoing FMT treatment; g)Received antibiotics for 3 consecutive days or more within 1 month before enrollment; h) Probiotic supplement treatment 1 month before enrollment; i)Infect HIV; j)Mental illness or mental retardation; k) Women who have a pregnancy plan or are breastfeeding within 18 months; l)Medical history of alcohol or drug abuse; m)Other situations that the researchers think are not suitable for participation in this project.

Design outcomes

Primary

MeasureTime frame
Treatment period of 6 months: Clinical remission (partial remission and complete remission) ;

Secondary

MeasureTime frame
Treatment period of 6 months: serum creatinine doubled from baseline; eGFR =30% lower than baseline; develop into ESRD ;Follow-up for 6 months after the end of the treatment period: clinical response (partial remission and complete remission); creatinine levels doubled from baseline; eGFR =30% lower than baseline; developed intothe ESRD;

Countries

China

Contacts

Public ContactShiren Sun

The First Affiliated Hospital of the Air Force Medical University

sunshiren@medmail.com.cn+86 136 7922 0706

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026