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

Overview

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.

Full Title of Study: “Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Detailed Description

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.

Interventions

  • Drug: tacrolimus combined with prednisone

Clinical Trial Outcome Measures

Primary Measures

  • complete remission of renal disease at 12 months

Secondary Measures

  • partial remission at 12 months and adverse events

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University
  • Overall Official(s)
    • Haiyan WANG, MD, Principal Investigator, Renal Division, Peking University First Hospital
    • Jianghua Chen, MD, Principal Investigator, Department of Nephrology, First Hospital of Zhejiang University
    • Xuewang Li, MD, Principal Investigator, Department of Nephrology, Peking Union Medical College Hospital
    • Fuming Lu, MD, Principal Investigator, Department of Nephrology, Huashan Hospital, Fudan University
    • Feifei Xu, MD, Principal Investigator, Department of Nephrology, First Hospital of Wenzhou Medical College
    • Jiaqi Qian, MD, Principal Investigator, Department of Nephrology, Renji Hospital of Shanghai
    • Fanfan Hou, MD, Principal Investigator, Department of Nephrology, Nanfang Hospital, First Military Medical University

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