Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome

Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).

This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.

Inclusion Criteria:

• Male or female 18 - 65 years of age
• First histologic diagnosis of MCNS
• Proteinuria > 3.5 g/day
• Patients who are willing to give written, informed consent

Exclusion Criteria:

• Presence of secondary causes of MCNS
• History of glomerular disease including MCNS
• eGFR < 50 ml/min/1.73m2
• Renal histology showing pathologies other than MCNS
• Female of child-bearing age who are unwilling to practice effective contraception
• Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study