NCT01895894

Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrotic Syndrome

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil	Mycophenolate mofetil 20\~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-07-11
• Last updated: 2017-07-06

Locations

1 site across 1 country: South Korea