Kidney Res Clin Pract.
2017 Jun;36(2):159-166. 10.23876/j.krcp.2017.36.2.159.
Efficacy and safety of adding mizoribine to standard treatment in patients with immunoglobulin A nephropathy: A randomized controlled trial
- Affiliations
-
- 1Division of Nephrology, First Department of Integrated Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan. su-ooka@hb.tp1.jp
- 2Department of Nephrology, Saiseikai Kawaguchi General Hospital, Saitama, Japan.
- 3Saitama Social Insurance Hospital, Saitama, Japan.
- 4Department of Nephrology, Dokkyo University Koshigaya Medical Center, Saitama, Japan.
- 5Department of Public Health, Jichi Medical University, Tochigi, Japan.
- 6Department of Internal Medicine, Mimami-uonuma City Hospital, Niigata, Japan.
- KMID: 2384618
- DOI: http://doi.org/10.23876/j.krcp.2017.36.2.159
Abstract
- 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.
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