title: 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.
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.
authors.affiliation: Division of Nephrology and Hypertension , IIS-Fundación Jiménez Díaz, School of Medicine, Universidad Autónoma de Madrid (UAM) and FRIAT , Madrid , Spain ; Spanish Renal Research Network (REDINREN) , Madrid , Spain.
authors.forename: Jorge
authors.initials: J
authors.lastname: Rojas-Rivera
authors.affiliation: Spanish Renal Research Network (REDINREN) , Madrid , Spain ; Division of Nephrology , Hospital Universitario Fundación Alcorcón , Madrid , Spain.
authors.forename: Gema
authors.initials: G
authors.lastname: Fernández-Juárez
authors.affiliation: Division of Nephrology and Hypertension , IIS-Fundación Jiménez Díaz, School of Medicine, Universidad Autónoma de Madrid (UAM) and FRIAT , Madrid , Spain ; Spanish Renal Research Network (REDINREN) , Madrid , Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Ortiz
authors.affiliation: Department of Nephrology , Radboud University Nijmegen Medical Center , Nijmegen , The Netherlands.
authors.forename: Julia
authors.initials: J
authors.lastname: Hofstra
authors.affiliation: Struttura Complessa di Nefrologia Dialisi e Trapianto Ospedaliero-Universitaria , Foggia , Italy.
authors.forename: Loreto
authors.initials: L
authors.lastname: Gesualdo
authors.affiliation: Department of Nephrology , 1st School of Medicine, Charles University and General University Hospital , Prague , Czech Republic.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Tesar
authors.affiliation: Department of Nephrology , Radboud University Nijmegen Medical Center , Nijmegen , The Netherlands.
authors.forename: Jack
authors.initials: J
authors.lastname: Wetzels
authors.affiliation: Spanish Renal Research Network (REDINREN) , Madrid , Spain ; Division of Nephrology , Hospital Vall d' Hebron , Barcelona, Catalonia , Spain.
authors.forename: Alfons
authors.initials: A
authors.lastname: Segarra
authors.affiliation: Division of Nephrology and Hypertension , IIS-Fundación Jiménez Díaz, School of Medicine, Universidad Autónoma de Madrid (UAM) and FRIAT , Madrid , Spain.
authors.forename: Jesus
authors.initials: J
authors.lastname: Egido
authors.affiliation: Spanish Renal Research Network (REDINREN) , Madrid , Spain ; Division of Nephrology , Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid , Madrid , Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Praga
keywords: biomarker; immunosuppression; membranous nephropathy; nephrotic syndrome; randomized controlled trial