Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial

Kosuke Masutani, Akihiro Tsuchimoto, Tomomi Yamada, Makoto Hirakawa, Koji Mitsuiki, Ritsuko Katafuchi, Hideki Hirakata, Takanari Kitazono, Kazuhiko Tsuruya, Japan Study Group for Therapy of IgA Nephropathy Investigators West Japan Study Group for Therapy of IgA Nephropathy Investigators

Research output: Contribution to journalArticle

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Abstract

Background: The significance of immunosuppressants as an adjunct treatment with corticosteroids for IgA nephropathy (IgAN) has not been well demonstrated. This study was performed to compare two treatment regimens, steroid-pulse therapy or combined with mizoribine (MZR) in progressive IgAN. Methods: Study design was a prospective randomized controlled trial of 40 patients with moderate to severe glomerular injuries who were randomly administered either pulse methylprednisolone followed by a 25-month course of oral prednisolone (P group, n = 20) or in combination with MZR (150 mg/day for 24 months, M + P group, n = 20). The primary endpoint was a reduction of proteinuria by ≥50 % of the baseline value. Secondary endpoints were increased serum creatinine (Cr) by ≥50 %, or a decrease in estimated glomerular filtration rate by ≤50 %. Results: Twenty-five months after the initiation of treatment, urinary protein excretion significantly declined from the median of 0.98 to 0.17 g/gCr in the P group (P < 0.05) and from 1.01 to 0.38 g/gCr in the M + P group (P < 0.05). There was no statistical difference in the serial changes of proteinuria between two groups (P = 0.81). All patients reached the primary endpoint, and the cumulative incidence of the reduction of proteinuria was not significantly different (P = 0.76). No patient reached the secondary endpoint during the 25 months of treatment. Conclusions: Both therapeutic regimens significantly reduced the levels of proteinuria. We could not find the additional effect of MZR in combination with steroid-pulses in this small-scale controlled trial. Steroid-pulse therapy with a 25-month course of oral steroids seems to be effective for progressive IgAN.

Original languageEnglish
Pages (from-to)896-903
Number of pages8
JournalClinical and Experimental Nephrology
Volume20
Issue number6
DOIs
Publication statusPublished - Dec 1 2016

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Immunoglobulin A
Randomized Controlled Trials
Steroids
Proteinuria
Therapeutics
Methylprednisolone
Immunosuppressive Agents
Prednisolone
bredinin
Glomerular Filtration Rate
Creatinine
Adrenal Cortex Hormones
Incidence
Wounds and Injuries
Serum
Proteins

All Science Journal Classification (ASJC) codes

  • Physiology
  • Nephrology
  • Physiology (medical)

Cite this

Masutani, K., Tsuchimoto, A., Yamada, T., Hirakawa, M., Mitsuiki, K., Katafuchi, R., ... West Japan Study Group for Therapy of IgA Nephropathy Investigators, J. S. G. F. T. O. I. N. I. (2016). Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial. Clinical and Experimental Nephrology, 20(6), 896-903. https://doi.org/10.1007/s10157-016-1226-3

Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy : a randomized controlled trial. / Masutani, Kosuke; Tsuchimoto, Akihiro; Yamada, Tomomi; Hirakawa, Makoto; Mitsuiki, Koji; Katafuchi, Ritsuko; Hirakata, Hideki; Kitazono, Takanari; Tsuruya, Kazuhiko; West Japan Study Group for Therapy of IgA Nephropathy Investigators, Japan Study Group for Therapy of IgA Nephropathy Investigators.

In: Clinical and Experimental Nephrology, Vol. 20, No. 6, 01.12.2016, p. 896-903.

Research output: Contribution to journalArticle

Masutani, K, Tsuchimoto, A, Yamada, T, Hirakawa, M, Mitsuiki, K, Katafuchi, R, Hirakata, H, Kitazono, T, Tsuruya, K & West Japan Study Group for Therapy of IgA Nephropathy Investigators, JSGFTOINI 2016, 'Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial', Clinical and Experimental Nephrology, vol. 20, no. 6, pp. 896-903. https://doi.org/10.1007/s10157-016-1226-3
Masutani, Kosuke ; Tsuchimoto, Akihiro ; Yamada, Tomomi ; Hirakawa, Makoto ; Mitsuiki, Koji ; Katafuchi, Ritsuko ; Hirakata, Hideki ; Kitazono, Takanari ; Tsuruya, Kazuhiko ; West Japan Study Group for Therapy of IgA Nephropathy Investigators, Japan Study Group for Therapy of IgA Nephropathy Investigators. / Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy : a randomized controlled trial. In: Clinical and Experimental Nephrology. 2016 ; Vol. 20, No. 6. pp. 896-903.
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abstract = "Background: The significance of immunosuppressants as an adjunct treatment with corticosteroids for IgA nephropathy (IgAN) has not been well demonstrated. This study was performed to compare two treatment regimens, steroid-pulse therapy or combined with mizoribine (MZR) in progressive IgAN. Methods: Study design was a prospective randomized controlled trial of 40 patients with moderate to severe glomerular injuries who were randomly administered either pulse methylprednisolone followed by a 25-month course of oral prednisolone (P group, n = 20) or in combination with MZR (150 mg/day for 24 months, M + P group, n = 20). The primary endpoint was a reduction of proteinuria by ≥50 {\%} of the baseline value. Secondary endpoints were increased serum creatinine (Cr) by ≥50 {\%}, or a decrease in estimated glomerular filtration rate by ≤50 {\%}. Results: Twenty-five months after the initiation of treatment, urinary protein excretion significantly declined from the median of 0.98 to 0.17 g/gCr in the P group (P < 0.05) and from 1.01 to 0.38 g/gCr in the M + P group (P < 0.05). There was no statistical difference in the serial changes of proteinuria between two groups (P = 0.81). All patients reached the primary endpoint, and the cumulative incidence of the reduction of proteinuria was not significantly different (P = 0.76). No patient reached the secondary endpoint during the 25 months of treatment. Conclusions: Both therapeutic regimens significantly reduced the levels of proteinuria. We could not find the additional effect of MZR in combination with steroid-pulses in this small-scale controlled trial. Steroid-pulse therapy with a 25-month course of oral steroids seems to be effective for progressive IgAN.",
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AU - Masutani, Kosuke

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AU - Yamada, Tomomi

AU - Hirakawa, Makoto

AU - Mitsuiki, Koji

AU - Katafuchi, Ritsuko

AU - Hirakata, Hideki

AU - Kitazono, Takanari

AU - Tsuruya, Kazuhiko

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