Clinical Trial: Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective, Randomized, Open-label Study Evaluating the Efficacy of Mycophenolate Mofetil in the Prevention of Relapse of Steroid Dependent Nephrotic Syndrome in Childr

Brief Summary:

Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients need other immunosuppressants to reduce steroid dependency. The long-term use should be restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.

Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have similar efficacy and fewer undesirable effects to other drugs in mainly observational studies. To determine the efficacy of mycophenolate mofetil in the management of steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized controlled study.

Detailed Summary:
Sponsor: Seoul National University Hospital

Current Primary Outcome: relapse free time [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: remission maintenance rate at 3, 6, 9, 12 months [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: July 7, 2013
Date Started: September 2013
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015