MEmbranous Nephropathy Trial Of Rituximab

Completed · Phase 2/Phase 3

Conditions studied: Idiopathic Membranous Nephropathy

In brief

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.

Key facts

Study ID

NCT01180036

Run by

Mayo Clinic

People needed

130

Starts

2011-11-01

Expected to finish

2017-10-01

Last updated by the study team

2019-04-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• University of Arizona, Tucson — Tucson, Arizona, United States
• Stanford University — San Francisco, California, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of Miami Hospital and Clinics — Miami, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• New York University — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• MetroHealth System (Case Western Reserve University) — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Medical College of Wisconsin, Froedtert Hospital — Milwaukee, Wisconsin, United States
• St. Paul's Hospital, Providence Health Care — Vancouver, British Columbia, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec — Québec, Canada

Full record on ClinicalTrials.gov

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