Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome

Study Overview
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Brief Summary
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Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine. Tacrolimus, a new immunosuppressive agent, was proved to be effective in treating refractory NS. Whether it is effective in IMN has not been reported. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome.

Detailed Description
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Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs especially cyclophosphamide or cyclosporine. However, the effect was not satisfying and the side-effects of the above immunosuppressive agents were often a worrying problem. Tacrolimus, a new immunosuppressive agent, was proved to be effective in treating refractory NS especially FSGS. Whether it is effective in IMN has not been reported. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients with idiopathic membranous nephropathy and nephrotic syndrome.

Official Title
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Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome

Conditions
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Idiopathic Membranous Nephropathy, Nephrotic Syndrome

Intervention / Treatment
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* Drug: tacrolimus combined with prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients were diagnosed as idiopathic membranous nephropathy according to renal histology, with nephrotic syndrome, serum creatinine less than 2.5mg/dL, 18 70 years old, signed the informed consent and willing to be followed up according to the protocol. Exclusion Criteria: Patients who had received immunosuppressive therapy within the previous 3 months, complicated other severe renal diseases, serum creatinine higher than 2.5mg/dL, severe infection, diabetes mellitus, liver disease, pregnancy, lactating, and anticipated poor compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tacrolimus combined with prednisone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission of renal disease at 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial remission at 12 months and adverse events |  |  |