At a glance
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A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy
In Brief
A Phase 3 clinical trial evaluating Mycophenolate mofetil, low dose steroid and Cyclosporin, low dose steroid for Glomerulonephritis, Membranous. Completed, enrolled 43 participants across 9 sites.
Detailed Summary
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.
Study Details
Timeline
Interventions
Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 \~ 1000 mg bid per day (more than 50kg) Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day Duration: 48 weeks
Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml) Steroid: same dosage with active comparator goup Duration: 48 weeks