NCT00302523

Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

Tacrolimus Treatment of Patients With Idiopathic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Nanjing University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Idiopathic Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	Tacrolimus	FK506,0.1mg/kg/d

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-12-01
• Completion: 2009-12-01
• First posted: 2006-03-14
• Last updated: 2012-02-03

Locations

2 sites across 1 country: China