Kosuke Masutani1, Akihiro Tsuchimoto1, Tomomi Yamada2, Makoto Hirakawa3, Koji Mitsuiki4, Ritsuko Katafuchi5, Hideki Hirakata4, Takanari Kitazono1, Kazuhiko Tsuruya6,7. 1. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 2. Department of Clinical Epidemiology and Biostatistics, Graduate School of Medicine, Osaka University, Suita, Japan. 3. Division of Nephrology, Harasanshin Hospital, Fukuoka, Japan. 4. Nephrology and Dialysis Center, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan. 5. Kidney Unit, National Fukuoka-Higashi Medical Center, Koga, Japan. 6. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. tsuruya@intmed2.med.kyushu-u.ac.jp. 7. Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan. tsuruya@intmed2.med.kyushu-u.ac.jp.
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.
RCT Entities:
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.
Entities:
Keywords:
Antimetabolite; Methylprednisolone; Oxford classification; Proteinuria; Renin-angiotensin system (RAS) inhibitor
Authors: K Sonda; K Takahashi; K Tanabe; S Funchinoue; Y Hayasaka; H Kawaguchi; S Teraoka; H Toma; K Ota Journal: Transplant Proc Date: 1996-12 Impact factor: 1.066
Authors: K Yoshioka; Y Ohashi; T Sakai; H Ito; N Yoshikawa; H Nakamura; T Tanizawa; H Wada; S Maki Journal: Kidney Int Date: 2000-07 Impact factor: 10.612
Authors: Ian S D Roberts; H Terence Cook; Stéphan Troyanov; Charles E Alpers; Alessandro Amore; Jonathan Barratt; Francois Berthoux; Stephen Bonsib; Jan A Bruijn; Daniel C Cattran; Rosanna Coppo; Vivette D'Agati; Giuseppe D'Amico; Steven Emancipator; Francesco Emma; John Feehally; Franco Ferrario; Fernando C Fervenza; Sandrine Florquin; Agnes Fogo; Colin C Geddes; Hermann-Josef Groene; Mark Haas; Andrew M Herzenberg; Prue A Hill; Ronald J Hogg; Stephen I Hsu; J Charles Jennette; Kensuke Joh; Bruce A Julian; Tetsuya Kawamura; Fernand M Lai; Lei-Shi Li; Philip K T Li; Zhi-Hong Liu; Bruce Mackinnon; Sergio Mezzano; F Paolo Schena; Yasuhiko Tomino; Patrick D Walker; Haiyan Wang; Jan J Weening; Nori Yoshikawa; Hong Zhang Journal: Kidney Int Date: 2009-07-01 Impact factor: 10.612