CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 130 enrolled
Drug / intervention
Rituximab +1 moredrug
Likely dose
Rituximab 1000 mgfrom 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/NCT01180036
NCT01180036Phase 3Completed
CompareCT.gov

"A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)"

Mayo Clinic·interventional·Posted Aug 11, 2010·Updated Apr 30, 2019

In Brief

A Phase 3 clinical trial evaluating Rituximab and Cyclosporine for Idiopathic Membranous Nephropathy. Completed, enrolled 130 participants across 21 sites in 2 countries.

Detailed Summary

The primary outcome of this study is to determine whether or not the B cell targeting with Rituximab is non-inferior or more effective than Cyclosporine in inducing long term remission of proteinuria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Membranous Nephropathy
CountriesCanada, United States
CollaboratorsColumbia University, University of British Columbia, Ohio State University, Stanford University, University of Washington, University of Michigan, University of Alabama at Birmingham, Case Western Reserve University, The Cleveland Clinic, University of Kansas Medical Center, University of Manchester, University Health Network, Toronto, University of Toronto, CHU de Quebec-Universite Laval, Washington University School of Medicine, Florida International University, University of Mississippi Medical Center, NYU Langone Health, Medical College of Wisconsin, University of Arizona, Sunnybrook Health Sciences Centre, Applied Health Research Centre, Fulk Family Foundation

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2010
Enrollment StartNov 1, 2011
Primary CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 15.9 years ago

Interventions

Rituximabdrug

1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of cluster of differentiation (CD) 19+ B cell count

Cyclosporinedrug

Patients randomized to the Cyclosporine arm will be started at a dose of (CsA = 3.5 mg/kg/day p.o. divided into 2 doses for 12 months). Target trough CsA blood levels, as determined in whole blood by High Performance Liquid Chromatography (HPLC), are 125 to 175 ng/ml. A persistent and otherwise unexplained increase in serum creatinine \>30% would prompt an approximate 25% dose reduction of CSA, aiming for a corresponding 25% reduction in CSA trough level. If with this dose reduction the creatinine does not return to within 30% of baseline levels within 3 weeks, then a second dose reduction of approximately 25% with similar reduction in CSA trough level will be used. If the creatinine does not fall to baseline values with this second dose reduction, the drug will be discontinued. At the end of 12 months, Cyclosporine will be tapered by 1/3 of the maintenance dose monthly and hence discontinued after 3 months.