MEmbranous Nephropathy Trial Of Rituximab

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.

Conditions

• Idiopathic Membranous Nephropathy

Interventions

DRUG

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

DRUG

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.

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• CHU de Quebec-Universite Laval

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Florida International University

  collaborator OTHER

• University of Mississippi Medical Center

  collaborator OTHER

• NYU Langone Health

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• Sunnybrook Health Sciences Centre

  collaborator OTHER

• Applied Health Research Centre

  collaborator OTHER

• Fulk Family Foundation

  collaborator UNKNOWN

• Mayo Clinic

  lead OTHER

Principal Investigators

• Fernando C. Fervenza, M.D., Ph.D. · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2017-10-01

Completion

2017-10-01

Countries

• United States
• Canada

Study Locations