Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

Idiopathic Membranous Nephropathy Clinical Trial

Official title: Tacrolimus Treatment of Patients With Idiopathic

Status Completed

Clinical Trial Summary

The purpose of this study is:

• To explore the potential role of tacrolimus in the treatment of membranous nephropathy.

• To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.

Clinical Trial Description

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Idiopathic Membranous Nephropathy
• Kidney Diseases

• NCT number: NCT00302523
• Study type: Interventional
• Source: Nanjing University School of Medicine
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Completion date: December 2009