130
Participants
Start Date
November 30, 2011
Primary Completion Date
October 1, 2017
Study Completion Date
October 1, 2017
Rituximab
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
Cyclosporine
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.
New York University, New York
Columbia University Medical Center, New York
Mayo Clinic Jacksonville, Jacksonville
University of Miami Hospital and Clinics, Miami
University of Alabama at Birmingham, Birmingham
University of Mississippi Medical Center, Jackson
Ohio State University, Columbus
MetroHealth System (Case Western Reserve University), Cleveland
Cleveland Clinic, Cleveland
University of Michigan, Ann Arbor
Medical College of Wisconsin, Froedtert Hospital, Milwaukee
Mayo Clinic Rochester, Rochester
Washington University School of Medicine, St Louis
University of Kansas Medical Center, Kansas City
Mayo Clinic Scottsdale, Scottsdale
University of Arizona, Tucson, Tucson
Stanford University, San Francisco
University of Washington Medical Center, Seattle
St. Paul's Hospital, Providence Health Care, Vancouver
Toronto General Hospital, Toronto
Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec, Québec
Lead Sponsor
Collaborators (1)
Columbia University
OTHER
University of British Columbia
OTHER
Ohio State University
OTHER
Stanford University
OTHER
University of Washington
OTHER
University of Michigan
OTHER
University of Alabama at Birmingham
OTHER
Case Western Reserve University
OTHER
The Cleveland Clinic
OTHER
University of Kansas Medical Center
OTHER
University of Manchester
OTHER
University Health Network, Toronto
OTHER
University of Toronto
OTHER
CHU de Quebec-Universite Laval
OTHER
Washington University School of Medicine
OTHER
Florida International University
OTHER
University of Mississippi Medical Center
OTHER
NYU Langone Health
OTHER
Medical College of Wisconsin
OTHER
University of Arizona
OTHER
Sunnybrook Health Sciences Centre
OTHER
Applied Health Research Centre
OTHER
Fulk Family Foundation
UNKNOWN
Mayo Clinic
OTHER