title: Comparison of steroid-pulse therapy and combined with mizoribine in IgA nephropathy: a randomized controlled trial.
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.
authors.affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Kosuke
authors.initials: K
authors.lastname: Masutani
authors.affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Tsuchimoto
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, Graduate School of Medicine, Osaka University, Suita, Japan.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Division of Nephrology, Harasanshin Hospital, Fukuoka, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Hirakawa
authors.affiliation: Nephrology and Dialysis Center, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Mitsuiki
authors.affiliation: Kidney Unit, National Fukuoka-Higashi Medical Center, Koga, Japan.
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Katafuchi
authors.affiliation: Nephrology and Dialysis Center, Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Hirakata
authors.affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Takanari
authors.initials: T
authors.lastname: Kitazono
authors.affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. tsuruya@intmed2.med.kyushu-u.ac.jp.|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.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Tsuruya
mesh_terms: D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D005260:Female; D005919:Glomerular Filtration Rate; D005922:Glomerulonephritis, IGA / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011446:Prospective Studies; D011507:Proteinuria / Q000188:drug therapy; D012263:Ribonucleosides / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D012263:Ribonucleosides; C010052:mizoribine; D008775:Methylprednisolone
keywords: Antimetabolite; Methylprednisolone; Oxford classification; Proteinuria; Renin-angiotensin system (RAS) inhibitor