A European Multicentre and Open-label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment with TAcrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients with Primary MEmbranous Nephropathy: the STARMEN Study

Overview

Journal Clin Kidney J

Publisher Oxford University Press

Specialty Nephrology

Date 2015 Sep 29

PMID 26413273

Citations 15

Authors

Jorge Rojas-Rivera

Gema Fernandez-Juarez

Alberto Ortiz

Julia Hofstra

Loreto Gesualdo

Vladimir Tesar

Jack Wetzels

Alfons Segarra

Jesus Egido

Manuel Praga

Affiliations

Soon will be listed here.

Abstract

Background: Patients with primary membranous nephropathy (MN) and persistent nephrotic syndrome have a high risk of progression to end-stage renal disease. The Ponticelli protocol (steroids with alkylating agents) is the most effective immunosuppressive therapy for this condition, but it has severe adverse effects. Tacrolimus and rituximab have demonstrated efficacy for remission of nephrotic syndrome in MN with a safer profile. However, the published evidence is largely based on small or short-term observational studies, historical cohorts, comparisons with conservative therapy or clinical trials without appropriate control groups, and there is no head-to-head comparison with the Ponticelli protocol.

Methods: The STARMEN randomized clinical trial will compare the efficacy of sequential tacrolimus-rituximab therapy with a modified Ponticelli protocol (steroids plus cyclophosphamide). The trial will also evaluate the role of antibodies against the M-type phospholipase A2 receptor (anti-PLA2R) and other antibodies as markers of response to treatment and long-term prognosis.

Results: The trial has already started with 23 patients having been enrolled as of 1 April 2015, an estimated 21.7% of the estimated sample.

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