EMaCy trial

JRCT ID: jRCTs051200070

Registered date:22/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Frequently relapsing nephrotic syndrome in children
• Date of first enrollment: 23/12/2020
• Target sample size: 20
• Study type: Interventional

Intervention(s)

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).

Outcome(s)

• Primary Outcome: Rate of regression to treatment failure up to 52 weeks after starting cyclosporine weight loss

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 3age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Tanaka Yu