A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy

Claudio Ponticelli, Patrizia Passerini, Maurizio Salvadori, Carlo Manno, Battista Fabio Viola, Sonia Pasquali, Salvatore Mandolfo, Piergiorgio Messa

Research output: Contribution to journalArticle

120 Citations (Scopus)

Abstract

• Background: We conducted a pilot trial to compare the effectiveness and safety of 2 different treatments in patients with membranous nephropathy and nephrotic syndrome. Methods: To validate the hypothesis that the 2 treatments were equivalent, patients with biopsy-proven membranous nephropathy and nephrotic syndrome were randomly assigned to methylprednisolone alternated with a cytotoxic drug every other month for 6 months (group A) or to intramuscular synthetic adrenocorticotropic hormone administered twice a week for 1 year (group B). Results: The primary outcome measure is cumulative number of remissions as a first event. Fifteen of 16 patients in group A and 14 of 16 patients in group B entered complete or partial remission as a first event. After a median follow-up of 24 months (interquartile range, 15 to 25 months), there were 4 complete remissions and 8 partial remissions in group A versus 8 complete remissions and 6 partial remissions in group B. Median proteinuria decreased from protein of 5.1 g/d (interquartile range, 4.0 to 7.3 g/d) to 2.1 g/d (interquartile range, 0.4 to 3.8 g/d; P = 0.004) in group A and 6.0 g/d (interquartile range, 4.4 to 8.5 g/d) to 0.3 g/d (interquartile range, 0.2 to 1.9 g/d; P = 0.049) in group B. Two patients from each group interrupted treatment because of side effects or inefficacy. Conclusion: Most nephrotic patients with membranous nephropathy responded to either treatment. Proteinuria was significantly decreased with both methylprednisolone and cytotoxic agents or prolonged administration of synthetic adrenocorticotropic hormone, without significant differences between these 2 therapies.

Original languageEnglish
Pages (from-to)233-240
Number of pages8
JournalAmerican Journal of Kidney Diseases
Volume47
Issue number2
DOIs
Publication statusPublished - Feb 2006

Fingerprint

Membranous Glomerulonephritis
Cytotoxins
Methylprednisolone
Adrenocorticotropic Hormone
Nephrotic Syndrome
Proteinuria
Therapeutics
Outcome Assessment (Health Care)
Biopsy
Safety
Pharmaceutical Preparations
Proteins

Keywords

  • Adrenocorticotropic hormone
  • Cytotoxic treatment
  • Glomerulonephritis
  • Membranous nephropathy
  • Nephrotic syndrome

ASJC Scopus subject areas

  • Nephrology

Cite this

A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy. / Ponticelli, Claudio; Passerini, Patrizia; Salvadori, Maurizio; Manno, Carlo; Viola, Battista Fabio; Pasquali, Sonia; Mandolfo, Salvatore; Messa, Piergiorgio.

In: American Journal of Kidney Diseases, Vol. 47, No. 2, 02.2006, p. 233-240.

Research output: Contribution to journalArticle

Ponticelli, Claudio ; Passerini, Patrizia ; Salvadori, Maurizio ; Manno, Carlo ; Viola, Battista Fabio ; Pasquali, Sonia ; Mandolfo, Salvatore ; Messa, Piergiorgio. / A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy. In: American Journal of Kidney Diseases. 2006 ; Vol. 47, No. 2. pp. 233-240.
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T1 - A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy

AU - Ponticelli, Claudio

AU - Passerini, Patrizia

AU - Salvadori, Maurizio

AU - Manno, Carlo

AU - Viola, Battista Fabio

AU - Pasquali, Sonia

AU - Mandolfo, Salvatore

AU - Messa, Piergiorgio

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AB - • Background: We conducted a pilot trial to compare the effectiveness and safety of 2 different treatments in patients with membranous nephropathy and nephrotic syndrome. Methods: To validate the hypothesis that the 2 treatments were equivalent, patients with biopsy-proven membranous nephropathy and nephrotic syndrome were randomly assigned to methylprednisolone alternated with a cytotoxic drug every other month for 6 months (group A) or to intramuscular synthetic adrenocorticotropic hormone administered twice a week for 1 year (group B). Results: The primary outcome measure is cumulative number of remissions as a first event. Fifteen of 16 patients in group A and 14 of 16 patients in group B entered complete or partial remission as a first event. After a median follow-up of 24 months (interquartile range, 15 to 25 months), there were 4 complete remissions and 8 partial remissions in group A versus 8 complete remissions and 6 partial remissions in group B. Median proteinuria decreased from protein of 5.1 g/d (interquartile range, 4.0 to 7.3 g/d) to 2.1 g/d (interquartile range, 0.4 to 3.8 g/d; P = 0.004) in group A and 6.0 g/d (interquartile range, 4.4 to 8.5 g/d) to 0.3 g/d (interquartile range, 0.2 to 1.9 g/d; P = 0.049) in group B. Two patients from each group interrupted treatment because of side effects or inefficacy. Conclusion: Most nephrotic patients with membranous nephropathy responded to either treatment. Proteinuria was significantly decreased with both methylprednisolone and cytotoxic agents or prolonged administration of synthetic adrenocorticotropic hormone, without significant differences between these 2 therapies.

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KW - Cytotoxic treatment

KW - Glomerulonephritis

KW - Membranous nephropathy

KW - Nephrotic syndrome

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