EMaCy trial

Completed

• Conditions: Frequently relapsing nephrotic syndrome in children

• Registration Number: jRCTs051200070

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-22
• Study Start: 2020-12-23
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		Rate of regression to treatment failure up to 52 weeks after starting cyclosporine weight loss

Secondary Outcome Measures

Name	Time	Method
Period of progression to treatment failure		Period of progression to treatment failure after stopping cyclosporine weight loss
Recurrence-free rate		Recurrence-free rate after stopping cyclosporine weight loss
Recurrence-free period		Recurrence-free period after stopping cyclosporine weight loss
Rate of regression to treatment failure		Rate of regression to treatment failure after stopping cyclosporine weight loss
The blood level of mizoribine		The blood level of mizoribine
Safety of mizoribine		Safety of mizoribine