Idiopathic Membranous Nephropathy Clinical Trial
— MENTOROfficial title:
"A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)"
Verified date | April 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | October 1, 2017 |
Est. primary completion date | October 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec | Quebec | |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital, Providence Health Care | Vancouver | British Columbia |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | MetroHealth System (Case Western Reserve University) | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of Miami Hospital and Clinics | Miami | Florida |
United States | Medical College of Wisconsin, Froedtert Hospital | Milwaukee | Wisconsin |
United States | Columbia University Medical Center | New York | New York |
United States | New York University | New York | New York |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Stanford University | San Francisco | California |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | University of Washington Medical Center | Seattle | Washington |
United States | University of Arizona, Tucson | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | 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, New York University School of Medicine, 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 |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission Status | The number of subjects to reach the composite of maintaining complete remission or partial remission at 24 months after randomization will be the primary endpoint. | 24 months after randomization | |
Secondary | Remission Status | The number of subjects to reach either complete remission or partial remission at 12 months after randomization. | 12 months after randomization |
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