NCT00423098

Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Mycophenolate sodium	Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
DRUG	Prednisone	Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
DRUG	Methylprednisolone	All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-01-17
• Last updated: 2011-06-28
• Results posted: 2011-06-28

Locations

17 sites across 9 countries: Colombia, France, Germany, Greece, Hungary, Italy, Spain, Taiwan, United Kingdom