Overview

MEmbranous Nephropathy Trial Of Rituximab

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborators:
Applied Health Research Centre
Case Western Reserve University
CHU de Quebec-Universite Laval
Columbia University
Florida International University
Fulk Family Foundation
Medical College of Wisconsin
NYU Langone Health
Ohio State University
Stanford University
Sunnybrook Health Sciences Centre
The Cleveland Clinic
University Health Network, Toronto
University of Alabama at Birmingham
University of Arizona
University of British Columbia
University of Kansas Medical Center
University of Manchester
University of Michigan
University of Mississippi Medical Center
University of Toronto
University of Washington
Washington University School of Medicine
Treatments:
Cyclosporine
Cyclosporins
Rituximab
Criteria
Inclusion Criteria

- Idiopathic MN with diagnostic biopsy

- Female, must be post-menopausal, surgically sterile or practicing a medically approved
method of contraception(no birth-control pill)

- Must be off prednisone or mycophenolate mofetil for >1 month and alkylating agents for
>6 months.

- angiotensin-converting-enzyme inhibitor (ACEi) and/or Angiotensin II receptor blockers
(ARB), for >3 months prior to randomization and adequate blood pressure (target BP
<130/80 millimeter of mercury (mmHg) in >75% of the readings, but subjects with BP
<140/80 mmHg in >75% of the readings will be eligible). Patients with documented
evidence of >3 months treatment with maximal angiotensin II blockade, on an
3-hydroxy-3-methylglutaryl-CoA lyase (HMG-CoA) reductase inhibitor, and BP control (BP
<140/80 mmHg in >75% of the readings) who remain with proteinuria >5g/24h may enter
and be randomized to RTX/CSA without the need of the run-in/conservative phase of the
study.

- Proteinuria >5g/24h on two 24-hour urine collection collected within 14 days of each
other

- Estimated glomerular filtration rate (GFR) ≥40 ml/min/1.73m2 while taking ACEi/ARB
therapy OR quantified endogenous creatinine clearance >40 ml/min/1.73m2 based on a
24-hour urine collection.

Exclusion Criteria

- Presence of active infection or a secondary cause of MN (e.g. hepatitis B, systemic
lupus erythematosus (SLE), medications, malignancies). Testing for HIV, Hepatitis B
and C should have occurred <2 years prior to enrollment into the study.

- Type 1 or 2 diabetes mellitus: to exclude proteinuria secondary to diabetic
nephropathy. Patients who have recent history of steroid induced diabetes but no
evidence on renal biopsy performed within 6 months of entry into the study are
eligible for enrollment.

- Pregnancy or breast feeding for safety reasons

- History of resistance to CSA (or other calcineurin inhibitors, e.g. tacrolimus), RTX
or alkylating agents (e.g. Cytoxan). Patients who previously responded to
CSA/Calcineurin Inhibitor (CNI), RTX or alkylating agents with either a complete
remission (CR) or partial remission (PR) but relapsed off CSA/CNI after 3 months or
relapsed off RTX or alkylating agent after 6 months are eligible.