A randomised and controlled study to assess the effect of cyclosporin in nephrotic patients with membranous nephropathy and reduced renal function (cyclomen)

W. Laurens, P. Ruggenenti, A. Perna, Y. Vanrenterghem, G. Remuzzi

Research output: Contribution to journalArticle

Abstract

This will be a three-and-a-half year, prospective, multicenter, randomised trial to compare the longterm effect of cyclosporin A (CsA) versus no immunosuppressive treatment on the outcome of renal function and histological changes in 186 patients with idiopathic membranous glomerulonephritis (IMN), reduced renal function and persistent severe nephrotic syndrome. Before randomisation, 24-hour proteinuria, serum creatinine and creatinine clearance will be measured in all patients with IMN diagnosed on a renal biopsy in the year preceding study entry. All eligible patients will be put on a low salt diet and an ACE-inhibitor in the 2 months preceding randomisation. They will be randomly allocated to treatment with either CsA or supportive therapy for 6 months, after stratification for previous immunosuppressive therapy. Patient recruitment will be restricted to 18 months and after randomisation they will be followed up for 42 months. CsA dosage will be adjusted according to blood trough levels and its effect on serum creatinine measured every week the first month and at 1, 2, 3, 6 months. Serum creatinine and creatinine clearance will be measured at 1, 2, 3, 6, 7, 9 months, and then every 3 months till the end of the study. Before study entry, a renal biopsy will be performed at 6 and 42 months to study histologic disease parameters and possible superimposed CsA-nephrotoxicity.

Original languageEnglish
Pages (from-to)237-247
Number of pages11
JournalJournal of Nephrology
Volume7
Issue number4
Publication statusPublished - 1994

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Keywords

  • ACE-inhibition
  • cyclosporin
  • membranous nephropathy

ASJC Scopus subject areas

  • Nephrology

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