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

NCT00362531 | Completed Phase 2

• 2 other identifiers: PRGNSCN01-0NCT00268567
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Membranous Nephropathy; Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• complete remission of renal disease at 12 months

Secondary Outcomes (1)

• partial remission at 12 months and adverse events

Interventions

tacrolimus combined with prednisone DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Related Publications (1)

• 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.

  PMID: 34778952 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Nephrotic Syndrome

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Nephrosis

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Haiyan WANG, MD

  Renal Division, Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Jianghua Chen, MD

  Department of Nephrology, First Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

• Xuewang Li, MD

  Department of Nephrology, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Fuming Lu, MD

  Department of Nephrology, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• Feifei Xu, MD

  Department of Nephrology, First Hospital of Wenzhou Medical College

  PRINCIPAL INVESTIGATOR

• Jiaqi Qian, MD

  Department of Nephrology, Renji Hospital of Shanghai

  PRINCIPAL INVESTIGATOR

• Fanfan Hou, MD

  Department of Nephrology, Nanfang Hospital, First Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 10, 2006
• Study Start: November 1, 2004
• Study Completion: January 1, 2007
• Last Updated: August 10, 2006

Record last verified: 2006-01