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Prospective single-arm clinical study on the efficacy and safety of tacrolimus "titration therapy" in high-risk idiopathic membranous nephropathy patients

Prospective single-arm clinical study on the efficacy and safety of tacrolimus "titration therapy" in high-risk idiopathic membranous nephropathy patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081948
Enrollment
Unknown
Registered
2024-03-16
Start date
2024-03-16
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

high-risk idiopathic membranous nephropathy

Interventions

test group:tacrolimus
prednisone

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1: Age =18 years old 2: Biopsy-confirmed diagnosis of MN within 24 months prior to enrollment 3: Diagnosis of IMN after exclusion of secondary, genetic factors 4: Diagnosed as high risk by KDIGO 2021 risk stratification for disease progression 5: No use of any immunosuppressive agents (e.g., rituximab, steroids, alkylating agents, calcineurin inhibitors, synthetic ACTH, MMF, azathioprine, etc.) within the previous 6 months 6: Serum creatinine level < 133 umol/L 7: Agree to sign an informed consent form and follow medical advice

Exclusion criteria

Exclusion criteria: 1: Presence of active infectious diseases in the patient (tested before inclusion in the study): e.g. hepatitis B and C, HIV, tuberculosis and syphilis 2: Patient is diagnosed with secondary MN (e.g., systemic lupus erythematosus (SLE)) 3: Patient has malignant tumor 4: Fasting blood glucose > 6.2 mmol/L 5: Presence of renal vein thrombosis detected by renal ultrasound (US) or CT scanning 6: Patient is pregnant or breastfeeding 7: Presence of life-threatening complications, such as heart failure or active gastrointestinal bleeding 8: Researchers determine other situations that are not suitable for inclusion in the study

Design outcomes

Primary

MeasureTime frame
Remission rate at 24 weeks of treatment (percent of patients with CR+PR);

Secondary

MeasureTime frame
Rate of patients with recurrence of IMN during the maintenance treatment period;Remission rate at 41248 weeks of treatment (percent of patients with CR+PR);Adverse event rate;PLA2R titers at 4, 12, 24, and 48 weeks of treatment;

Countries

China

Contacts

Public ContactHeng Li

The First Affiliated Hospital, College of Medicine, Zhejiang University

1308005@zju.edu.cn+86 135 8874 5375

Outcome results

None listed

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