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2017 ; 36
(2
): 159-166
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Efficacy and safety of adding mizoribine to standard treatment in patients with
immunoglobulin A nephropathy: A randomized controlled trial
#MMPMID28680823
Hirai K
; Ookawara S
; Kitano T
; Miyazawa H
; Ito K
; Ueda Y
; Kaku Y
; Hoshino T
; Mori H
; Yoshida I
; Kubota K
; Yamaji Y
; Takeda T
; Nakamura Y
; Tabei K
; Morishita Y
Kidney Res Clin Pract
2017[Jun]; 36
(2
): 159-166
PMID28680823
show ga
BACKGROUND: Mizoribine (MZR) is an immunosuppressive drug used in Japan for
treating patients with lupus nephritis and nephrotic syndrome and has been also
reportedly effective in patients with immunoglobulin A (IgA) nephropathy.
However, to date, few randomized control studies of MZR are performed in patients
with IgA nephropathy. Therefore, this prospective, open-label, randomized,
controlled trial aimed to investigate the efficacy and safety of adding MZR to
standard treatment in these patients, and was conducted between April 1, 2009,
and March 31, 2016, as a multicenter study. METHODS: Patients were randomly
assigned (1:1) to receiving standard treatment plus MZR (MZR group) or standard
treatment (control group). MZR was administered orally at a dose of 150 mg once
daily for 12 months. RESULTS: Primary outcomes were the percentage reduction in
urinary protein excretion from baseline and the rate of patients with hematuria
disappearance 36 months after study initiation. Secondary outcomes were the rate
of patients with proteinuria disappearance, clinical remission rate, absolute
changes in estimated glomerular filtration rate from baseline, and the change in
daily dose of prednisolone. Forty-two patients were randomly assigned to MZR (n =
21) and control groups (n = 21). Nine patients in MZR group and 15 patients in
the control group completed the study. No significant differences were observed
between the two groups with respect to primary and secondary outcomes.
CONCLUSION: The addition of MZR to standard treatment has no beneficial effect on
reducing urinary protein excretion and hematuria when treating patients with IgA
nephropathy.