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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: The University of Hong Kong

Current Primary Outcome: Complete remission (24 hour urine protein < 0.3 g) [ Time Frame: at 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection [ Time Frame: at 6 months ]

Original Secondary Outcome: Same as current

Information By: The University of Hong Kong

Dates:
Date Received: August 13, 2010
Date Started: September 2010
Date Completion: December 2018
Last Updated: October 25, 2016
Last Verified: October 2016