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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.

Rojas-Rivera J, Fernández-Juárez G, Ortiz A, Hofstra J, Gesualdo L, Tesar V, Wetzels J, Segarra A, Egido J, Praga M - Clin Kidney J (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

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.

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.

No MeSH data available.


Related in: MedlinePlus

Schematic overview of the STARMEN study. CYC, cyclophosphamide; TAC, tacrolimus; RTX, rituximab.
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SFV075F1: Schematic overview of the STARMEN study. CYC, cyclophosphamide; TAC, tacrolimus; RTX, rituximab.

Mentions: Proportion of patients with drug-related adverse events during the study.


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.

Rojas-Rivera J, Fernández-Juárez G, Ortiz A, Hofstra J, Gesualdo L, Tesar V, Wetzels J, Segarra A, Egido J, Praga M - Clin Kidney J (2015)

Schematic overview of the STARMEN study. CYC, cyclophosphamide; TAC, tacrolimus; RTX, rituximab.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4581392&req=5

SFV075F1: Schematic overview of the STARMEN study. CYC, cyclophosphamide; TAC, tacrolimus; RTX, rituximab.
Mentions: Proportion of patients with drug-related adverse events during the study.

Bottom Line: 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.

View Article: PubMed Central - PubMed

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.

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.

No MeSH data available.


Related in: MedlinePlus