CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Mycophenolate sodium +2 moredrug
Likely dose
Mycophenolate sodium 1440mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00423098
NCT00423098Phase 2Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Jan 17, 2007·Updated Jun 28, 2011

In Brief

A Phase 2 clinical trial evaluating Mycophenolate sodium, Prednisone, and 1 other intervention for Lupus Nephritis. Completed, enrolled 81 participants across 17 sites in 9 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesColombia, France, Germany, Greece, Hungary, Italy, Spain, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartFeb 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 19.5 years ago

Interventions

Mycophenolate sodiumdrug

Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.

Prednisonedrug

Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.

Methylprednisolonedrug

All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.