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Efficacy of mizoribine after two years of cyclosporine treatment for children with frequently relapsing nephrotic syndrome

EMaCy trial

4

The median age of enrolled patients was 4.5 years (range 3-8 years), 4 males and 0 females.

The enrollment pace was significantly slower than expected, and the planned number of enrollments was not reached during the enrollment period. Three of the four patients completed the protocol. The remaining patient was discontinued because of desire to change treatment from the protocol.

There is no severe adverse event during the conduct of the clinical study or after the study was completed.

Statistical analysis was not possible due to the small number of enrolled cases. None of the patients regressed to treatment failure (regression rate: 0%). Recurrence was observed in 1 of 3 patients (recurrence rate: 33%). Blood levels of mizoribine were not measured.

Statistical analysis could not be performed on the preventive efficacy of mizoribine after cyclosporine treatment with frequently relapsing nephrotic syndrome. However, none of her 3 treated cases showed frequent relapses, suggesting a protective effect against frequent relapses.

Mar. 31, 2023

No

There is no plan to share IPD.

https://jrct.mhlw.go.jp/latest-detail/jRCTs051200070

Tanaka Yu

Wakayama Medical University Hospital

811-1 Kimiidera, Wakayama City, Wakayama, Japan

tanaka-y@wakayama-med.ac.jp

Tanaka Yu

Wakayama Medical University Hospital

811-1 Kimiidera, Wakayama City, Wakayama, Japan

+81-73-441-0633

tanaka-y@wakayama-med.ac.jp

Complete

Oct. 22, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Written informed consent from the patients' parents or legal guardians.
2. Treated with 2-year cyclosporine after diagnosis of frequently relapsing nephrotic syndrome between one and 18 years of age.
3. Patients in remission at enrollment.
4. Patients with more than 3,000/mm^3 blood leukocytes

1. Prior treatment other than cyclosporine or steroids at relapse for frequent relapsing nephrotic syndrome
2. History of secondary nephrotic syndrome by other nephritis or systemic disease revealed by renal biopsy, clinical findings or blood tests
3. Frequency relapse while taking cyclosporine
4.Immunosuppressive drugs other than cyclosporine
5.Uncontrollable hypertension
6.Renal dysfunction(CCr<=60ml/min/1.73m2)
7.Active infectious disease
8.Schedule of live vaccine administration during this study
9.Severe liver dysfunction
10.Pregnant women
11.Otherwise judged inappropriate for this study by the physicians

Both

Frequently relapsing nephrotic syndrome in children

Treatment.
In this study, oral mizoribine (MZR, 4 mg/kg/day, Max 150 mg, once a day) is initiated when the dose of cyclosporine (CyA) tapering has begun. Both CyA and MZR are used for the first month. In the second month, the dose of CyA is reduced by half. In the third month, the dose of CyA is again reduced by half (1/4 of original dose). From the fourth month, CyA is discontinued (only MZR is continued).

Rate of regression to treatment failure up to 52 weeks after starting cyclosporine weight loss

Period of progression to treatment failure, recurrence-free rate and recurrence-free period, after starting cyclosporine weight loss
Rate of regression to treatment failure, period of progression to treatment failure, recurrence-free rate and recurrence-free period, after stopping cyclosporine weight loss
The blood level and safety of mizoribine

+81-73-441-0896

Aug. 06, 2020

none