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
EntityUAM. Departamento de Medicina; Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD)
PublisherOxford University Press
10.1093/ckj/sfv075Clinical Kidney Journal 8.5 (2015): 503-510
ISSN2048-8505 (print); 2048-8513 (on line)
Funded byThis is an investigator-initiated RCT that has been up to now funded by the European Renal Association (Research Programme, ERA-EDTA), the Instituto de Salud Carlos III (Spanish Government) through specific research projects (FIS 13/02502 and ICI14/00350) and the Spanish Renal Research Network (REDINREN, RD 012/0021).
ProjectGobierno de España. FIS 13/02502; Gobierno de España. ICI14/00350
SubjectsBiomarker; Immunosuppression; Membranous nephropathy; Nephrotic syndrome; Randomized controlled trial; Medicina
Rights© The Author 2015
Esta obra está bajo una licencia de Creative Commons Reconocimiento-NoComercial 4.0 Internacional.
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 Mtype phospholipaseA2 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
Google Scholar:Rojas-Rivera, Jorge - Fernández-Juárez, Gema - Ortiz Arduán, Alberto - Hofstra, Julia - Gesualdo, Loreto - Tesar, Vladimir - Wetzels, Jack - Segarra, Alfons - Egido, Jesus - Praga, Manuel
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