Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tacrolimus Treatment of Patients With Idiopathic

Conditions
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Idiopathic Membranous Nephropathy

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven idiopathic membranous nephropathy Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl Age 18-60 years with informed consent Exclusion Criteria: Patient with abnormal liver function tests Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days Active/serious infection Patient with hepatitis B surface antigen or who is hepatitis C antibody positive Patient who is diabetic Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FK506<br> | Drug: Tacrolimus<br>* FK506,0.1mg/kg/d<br>* Other names: Tacrolimus,Prograf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the potential role of tacrolimus in the treatment of membranous nephropathy. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse. |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Membranous Nephropathy, Treatment, Tacrolimus, Cyclophosphamide