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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075319
Enrollment
Unknown
Registered
2023-09-01
Start date
2023-09-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

IgA 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: 1. Aged 18-70 years old; 2. Pathologically diagnosed as primary IgAN, eGFR >= 30mL/min/1.73m2; 3. Initial treatment; 4. The quantity of 24-hour urinary protein is more than 0.75g and less than 3.5g; 5. Agree to participate in this project.

Exclusion criteria

Exclusion criteria: 1. The expected survival time of malignant tumors and other diseases is less than 3 months; 2. Severe cardio-cerebrovascular diseases and pulmonary insufficiency; 3. Complicated with other autoimmune diseases; 4. Diabetes; 5. Gastrointestinal tumors; 6. Gastrointestinal active bleeding; 7. Acute and chronic gastroenteritis; 8. Have previously received or are undergoing FMT treatment; 9. Infect HIV; 10. Mental illness or mental retardation; 11. Pregnant or lactating women within 11 or 18 months; 12. Medical history of alcohol or drug abuse; 13. Serious complications or comorbidities such as elevated aminotransferase more than 2 times the normal value, peripheral white blood cells < 4×10^9/L, deep venous thromboembolism; 14. Atypical IgAN (IgA deposition with glomerular minimal lesion, IgAN with acute renal injury and IgAN with rapidly progressive glomerulonephritis); 15. Other situations that the researchers think are not suitable for participate in this project.

Design outcomes

Primary

MeasureTime frame
The primary study outcome would be the 24-hour urinary protein quantity which is less than 0.75g/d during the treatment period (6 months);

Secondary

MeasureTime frame
The secondary study outcomes would be clinical remission (partial remission and complete remission), 24-hour urinary protein quantity greater than 3.5g/d, eGFR decrease by 30% from baseline, develop into ESRD and change in urinary occult blood during the treatment period.;The secondary study outcomes would be clinical remission (partial remission and complete remission), recurrence, 24-hour urinary protein quantity greater than 3.5g/d, eGFR decrease by 30% from baseline, develop into ESRD and change in urinary occult blood during follow-up for 6 months;

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