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Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen

Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031003
Enrollment
Unknown
Registered
2020-03-20
Start date
2020-03-25
Completion date
Unknown
Last updated
2020-03-23

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

Conditions

Idiopathic focal segmental glomerulosclerosis

Interventions

Tacrolimus group:Low dose of tacrolimus combined with hormone
hormone group:Use hormones

Sponsors

Southwest Hospital, the First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The subjects participated voluntarily, signed informed consent, and indicated that they were willing to accept both treatments; (2) Aged 13 to 60 years; (3) Idiopathic FSGS was confirmed by clinical and renal biopsy; (4) Urine protein quantity was more than 1000mg / 24h; (5) No immunosuppressant was used within 1 month before treatment; (6) All patients were treated with angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II receptor 1 blocker (ARB). (7) Be able to follow the research or follow-up procedures.

Exclusion criteria

Exclusion criteria: (1) Women with recent family planning, pregnancy or lactation; (2) Failure to understand the potential risks and benefits of the study and follow-up assessment as required; (3) No capacity for civil conduct; (4) History of drug or alcohol abuse; (5) Second, hepatitis B, Henoch Schonlein purpura, systemic lupus erythematosus and other secondary FSGS; (6) Hereditary nephropathy such as family history of nephropathy; (7) The immunosuppressants including azathioprine, mycophenolate mofetil, cyclosporine A and leflunomide were taken within one month before the start of the study; (8) Patients with severe infection, tumor, or other conditions considered unsuitable for clinical study by researchers.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein quantification;

Countries

China

Contacts

Public ContactHongwen Zhao

Southwest Hospital, the First Affiliated Hospital of Army Medical University

zhaohw212@126.com+86 13983360655

Outcome results

None listed

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