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NDT Advance Access published online on August 8, 2009
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfp390
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© The Author [2009]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Early versus late start of immunosuppressive therapy in idiopathic membranous nephropathy: a randomized controlled trial

Julia M. Hofstra1, Amanda J. W. Branten1, Joris J. J. M. Wirtz2, Ton C. Noordzij3, Peggy W. G. du Buf-Vereijken4 and Jack F. M. Wetzels1

1 Department of Nephrology, Radboud University Nijmegen Medical Centre, Nijmegen 2 Department of Internal Medicine, Laurentius Hospital, Roermond 3 Department of Internal Medicine, Franciscus Hospital, Roosendaal 4 Department of Internal Medicine, Amphia Hospital, Breda, The Netherlands

Correspondence and offprint requests to: Julia M. Hofstra; E-mail: J.Hofstra{at}nier.umcn.nl



  Abstract

Background. Immunosuppressive therapy in idiopathic membranous nephropathy (iMN) is debated. Accurate identification of patients at high risk for end-stage renal disease (ESRD) allows early start of therapy in these patients. It is unknown if early start of therapy is more effective and/or less toxic than late start (i.e. when GFR deteriorates).

Methods. We conducted a randomized open-label study in patients with iMN, a normal renal function and a high risk for ESRD (urinary β2m >0.5 µg/min, UIgG >125 mg/ day). Patients started with immunosuppressive therapy (cyclophosphamide for 12 months, and steroids) either immediately after randomization or when renal function deteriorated ({Delta}sCr ≥+25% and sCr >135 µmol/l or {Delta}sCr ≥+50%). End points were remission rates, duration of the nephrotic syndrome (NS), renal function and complications.

Results. The study included 26 patients (24 M/2 F), age 48 ± 12 years; sCr 96 µmol/l (range 68–126) and median proteinuria 10.0 g/10 mmol Cr. Early treatment resulted in a more rapid onset of remission (P = 0.003) and a shorter duration of the NS (P = 0.009). However, at the end of the follow-up (72 ± 22 m), there were no differences in overall remission rate, sCr (93 versus 105 µmol/l), proteinuria, relapse rate and adverse events.

Conclusions. In high-risk patients with iMN, immunosuppressive treatment is effective in inducing a remission. Early treatment shortens the duration of the nephrotic phase, but does not result in better preservation of renal function. Our study indicates that treatment decisions must be based on risk and benefit assessment in the individual patient.

Keywords: cyclophosphamide; immunosuppressive treatment; membranous nephropathy; randomized controlled trial; renal outcome

Received for publication: 27. 1.09
Accepted in revised form: 10. 7.09


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