Status:
COMPLETED
MEmbranous Nephropathy Trial Of Rituximab
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Columbia University
University of British Columbia
Conditions:
Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
In IMN, experimental data suggests that B cells are involved in the pathogenesis of the disease. To date, the best proven therapy for patients with MN consists of the combined use of corticosteroids a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01180036
Start Date
November 1 2011
End Date
October 1 2017
Last Update
April 30 2019
Active Locations (21)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85054
3
University of Arizona, Tucson
Tucson, Arizona, United States, 85724
4
Stanford University
San Francisco, California, United States, 94304