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Effect of single-dose oral mizoribine pulse therapy twice per week for frequently relapsing steroid-dependent nephrotic syndrome.

AbstractAIM:
To evaluate the efficacy of single-dose oral mizoribine (MZB) pulse therapy given twice weekly for frequently relapsing steroid-dependent nephrotic syndrome (FR-SDNS).
METHODS:
The subjects were 8 patients with FR-SDNS with a median age of 6.9 years old (range 3.1 - 18.0 y). The study was performed as a Phase II trial. The MZB dose was adjusted to achieve a peak blood level of 3 - 5 μg/ml (3.9 - 15.9 mg/kg/d, maximum dose: 750 mg) using a single dose given twice weekly before a meal. The therapeutic benefits of MZB pulse therapy were assessed based on a comparison of the incidence of relapse and the required daily dosage of prednisolone (PSL) in the 12 months prior to and following therapy.
RESULTS:
The incidence of relapse after therapy was significantly lower than that before therapy (2.5 ± 1.4 vs. 4.3 ± 0.5, p < 0.01) and the required daily dosage of prednisolone (PSL) after therapy was lower than that before therapy (0.48 ± 0.23 vs. 0.52 ± 0.32 mg/kg/d, not significant). However, this therapy was not effective for 3 out of 4 patients treated with cyclosporine. During follow-up, discontinuation of PSL was possible in 4 of 5 patients who showed a decreased rate of relapse after therapy. The peak blood concentration of MZB in these patients was significantly higher than that in 3 patients who did not show a decreased rate of relapse (3.95 ± 0.11 vs. 3.05 ± 0.21 μg/ml, p < 0.01). No adverse effects were observed in any patients.
CONCLUSION:
Our results show that single-dose oral MZB pulse therapy is effective in decreasing the frequency of relapse in some pediatric patients with FR-SDNS. A peak concentration of MZB of ~3.8 - 4.0 μg/ ml may be required for FR-SDNS therapy.
AuthorsMikiya Fujieda, Masayuki Ishihara, Taku Morita, Atsushi Hayashi, Shinichi Okada, Toshiyuki Ohta, Takashi Sakano, Hiroshi Wakiguchi
JournalClinical nephrology (Clin Nephrol) Vol. 78 Issue 1 Pg. 40-6 (Jul 2012) ISSN: 0301-0430 [Print] Germany
PMID22732336 (Publication Type: Clinical Trial, Phase II, Journal Article)
Chemical References
  • Immunosuppressive Agents
  • Ribonucleosides
  • Steroids
  • mizoribine
  • Cyclosporine
  • Prednisolone
Topics
  • Administration, Oral
  • Adolescent
  • Child
  • Child, Preschool
  • Cyclosporine (therapeutic use)
  • Female
  • Humans
  • Immunosuppressive Agents (administration & dosage, blood, pharmacokinetics)
  • Infant
  • Japan
  • Male
  • Nephrotic Syndrome (drug therapy)
  • Prednisolone (administration & dosage)
  • Pulse Therapy, Drug
  • Recurrence
  • Ribonucleosides (administration & dosage, blood, pharmacokinetics)
  • Steroids (administration & dosage)
  • Time Factors
  • Treatment Outcome

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