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
Entity
UAM. Departamento de Medicina; Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD)Publisher
Oxford University PressDate
2015-01-01Citation
10.1093/ckj/sfv075
Clinical Kidney Journal 8.5 (2015): 503-510
ISSN
2048-8505 (print); 2048-8513 (on line)DOI
10.1093/ckj/sfv075Funded by
This 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).Project
Gobierno de España. FIS 13/02502; Gobierno de España. ICI14/00350Editor's Version
http://dx.doi.org/10.1093/ckj/sfv075Subjects
Biomarker; Immunosuppression; Membranous nephropathy; Nephrotic syndrome; Randomized controlled trial; MedicinaRights
© The Author 2015Abstract
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
Files in this item
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
This item appears in the following Collection(s)
Related items
Showing items related by title, author, creator and subject.
-
Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial
Diago-Sempere, Elena; Bueno, José Luis; Sancho-López, Aránzazu; Muñez-Rubio, Elena; Torres, Ferrán; Malo de Molina, Rosa; Fernández-Cruz, Ana; Salcedo de Diego, Isabel; Velasco-Iglesias, Ana; Payares-Herrera, Concepción; Casas Flecha, Inmaculada; Avendaño Solá, Cristina
; Duarte Palomino, Rafael
; Ramos Martínez, Antonio
; Ruiz-Antorán, Belén
2021-01-20