Optimal use of ciclosporin in idiopathic membranous nephropathy associated with nephrotic syndrome

UMIN ID: UMIN000001099

Registered date:31/03/2008

Basic Information

• Health condition(s) or Problem(s) studied: idiopathic membranous nephropathy associated with nephrotic syndrome
• Date of first enrollment: 2007/10/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Steroid group: Immunosuppressive therapy is started by predonisolone 0.8mg/kg/day (max 60mg/day). The dose is decreased by 5mg/day in 2 to 4 weeks after remission. The cases who do not reach remission for 4 weeks, predonisolone is decreased to 0.6mg/kg/day, and ciclosporin (2mg/kg/day) is started once a day. Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.)
Steroid + ciclosporin group: Immunosupressive therapy is started by predonisolone 0.6mg/kg/day and ciclosporin 2mg/kg/day (once a day). Serum concentration of ciclosporin is measured 2hr after administration, and the dose is adjusted. (The target serum concentration is 800-1000ng/mL.) The dose of predonisolone is decreased by 5mg/day in 2 to 4 weeks after remission. Ciclosporin is continued after remission. (The target C2 is 600-800 ng/mL.) The cases who do not reach remission after 4 weeks, predonisolone is decreased by 5mg/4-8week, and ciclosporin is continued for 6 months. The target C2 is 800-1000ng/mL. At 6 months after, the therapy of non-respnder is not restricted.

Outcome(s)

• Primary Outcome: quantity of urinary protein, frequency of relapse, renal function (serum Cr, estimated GFR),time to remission, total dose of steroid (until remission)
• Secondary Outcome: adverse effects of steroid and ciclosporin, total dose of steroid (in all treatment period), duration of hospitalization, serum albumin, serum total protein, serum total cholesterol, degree of edema

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The cases who are considered inappropriate under "Guideline of ciclosporin therapy in nephrotic syndrome" or each doctor's decisions.

Related Information

• Primary Sponsor: Division of Kidney and Dialysis, Department of Internal Medicine,Hyogo College of Medicine
• Source(s) of Monetary Support: none