NCT01185197

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Nephrosis, Lipoid

Interventions

Type	Name	Description
DRUG	Myfortic plus low-dose steroid	Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off
DRUG	Prednisolone	1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician

Timeline

• Start date: 2010-09-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2010-08-19
• Last updated: 2018-06-01

Locations

1 site across 1 country: China