Abstract: SA-OR127
A Multi-Center Randomized Controlled Trial of Rituximab versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (MENTOR)
Session Information
- High-Impact Clinical Trials
November 02, 2017 | Location: Hall J, Morial Convention Center
Abstract Time: 12:15 PM - 12:30 PM
Category: Glomerular
- 1005 Clinical Glomerular Disorders
Authors
- Fervenza, Fernando C., Mayo Clinic, Rochester, Minnesota, United States
- Canetta, Pietro A., None, New York, New York, United States
- Barbour, Sean, University of British Columbia, Vancouver, British Columbia, Canada
- Lafayette, Richard A., Stanford University, Stanford, California, United States
- Rovin, Brad H., Ohio State University Wexner Medical Center, Columbus, Ohio, United States
- Aslam, Nabeel, Mayo Clinic Florida, Jacksonville, Florida, United States
- Hladunewich, Michelle A., University of Toronto, Toronto, Ontario, Canada
- Reich, Heather N., Toronto General Hospital, Toronto, Ontario, Canada
- Brenchley, Paul E., Manchester Royal Infirmary, Manchester, United Kingdom
- Gipson, Debbie S., University of Michigan, Ann Arbor, Michigan, United States
- Kretzler, Matthias, U.Michigan, Ann Arbor, Michigan, United States
- Radhakrishnan, Jai, Columbia University Medical Center, New York, New York, United States
- Hebert, Lee A., Ohio State University Medical Center, Columbus, Ohio, United States
- Gipson, Patrick E., University of Michigan, Ann Arbor, Michigan, United States
- Thomas, Leslie F., Mayo Clinic Arizona, Phoenix, Arizona, United States
- McCarthy, Ellen T., University of Kansas Medical Center, Kansas City, Kansas, United States
- Appel, Gerald B., Columbia University College of Physicians and Surgeons, Scarsdale, New York, United States
- Jefferson, J. Ashley, University of Washington, Seattle, Washington, United States
- Leung, Nelson, Mayo Clinic, Rochester, Minnesota, United States
- Cattran, Daniel C., Toronto General Hospital, Toronto, Ontario, Canada
Background
Membranous nephropathy (MN) remains the leading cause of nephrotic syndrome in Caucasian adults. Cyclosporine (CSA) is successful in reducing proteinuria, but its use is associated with a high relapse rate. Rituximab (RTX) is effective in reducing proteinuria but whether RTX is as effective as CSA in inducing and maintaining complete (C) or partial remission (PR) of proteinuria in MN is unknown. The MENTOR trial hypothesized that B-cell targeting with RTX is non-inferior to CSA in inducing long-term remission of proteinuria.
Methods
Patients with proteinuria ≥5g/24h, estimated GFR ≥ 40 ml/min/1.73m2 and ≥3-months of AII blockade were randomized into a 12-month treatment period with IV RTX, 1000 mg (2 infusions, 14 days apart; repeated at 6 months if proteinuria reduction >25% at 6-months or oral cyclosporine 3.5-5mg/kg/day for 6-months (continued for another 6-months if a substantial reduction in proteinuria (equal to or >25%) is seen at 6-months). Treatment efficacy was assessed by an intention-to-treat analysis of remission status (C or PR) at 24-months post-randomization. At the 6-month post-randomization, patients who did not have proteinuria reduction ≥25% were considered treatment failures and exit the study. Follow up was at 3, 6, 9, 12, 18 and 24 months, and included quantification of creatinine clearance, serum albumin, 24h proteinuria, anti-PLA2R antibodies levels as well as quality of life assessment.
Results
One hundred and eighty one were screened and 130 patients (mean age 52 ± 12.4 SD; 76.9% male) were randomized. Mean BP 125/76 ± 14 mmHg. Median SCr 1.2 mg/dl (range 0.5-2.5), serum albumin 2.6 g/dl (range 1.6-4.1), proteinuria 10.3 g/24h (range 8.9-27-5).
Conclusion
Last patient randomized was September 2015 and follow-up will be completed on 9/11/2017. We guarantee that will be able to present preliminary results by the time of the ASN.
Funding
- Commercial Support –