Clinical trial NCT00362531: Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Official title: Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Idiopathic Membranous Nephropathy
Nephrotic Syndrome
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2006-08-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: complete remission of renal disease at 12 months
Secondary outcomes:
measure: partial remission at 12 months and adverse events
Other outcomes:
Locations:
Study officials:
affiliation: Renal Division, Peking University First Hospital
name: Haiyan WANG, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, First Hospital of Zhejiang University
name: Jianghua Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Peking Union Medical College Hospital
name: Xuewang Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Huashan Hospital, Fudan University
name: Fuming Lu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, First Hospital of Wenzhou Medical College
name: Feifei Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Renji Hospital of Shanghai
name: Jiaqi Qian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, Nanfang Hospital, First Military Medical University
name: Fanfan Hou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.