Idiopathic Membranous Nephropathy
Conditions
Keywords
Idiopathic Membranous Nephropathy, Treatment, Tacrolimus, Cyclophosphamide
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 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.
Interventions
DRUGTacrolimus
FK506,0.1mg/kg/d
Sponsors
Nanjing University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To explore the potential role of tacrolimus in the treatment of membranous nephropathy. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse. | 18 months |
Countries
China
Outcome results
None listed