Clinical Trial: Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Tacrolimus Treatment of Patients With Idiopathic
Brief 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 Summary: 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.
Sponsor: Nanjing University School of Medicine
Current Primary Outcome: To explore the potential role of tacrolimus in the treatment of membranous nephropathy. [ Time Frame: 18 months ]
Original Primary Outcome: To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
Current Secondary Outcome: To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse. [ Time Frame: 18 months ]
Original Secondary Outcome: To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.
Information By: Nanjing University School of Medicine
Dates:
Date Received: March 13, 2006
Date Started: March 2006
Date Completion:
Last Updated: February 2, 2012
Last Verified: February 2012
