Frequently relapsing nephrotic syndrome in children
Conditions
Interventions
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.
Sponsors
Tanaka Yu
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of regression to treatment failure up to 52 weeks after starting cyclosporine weight loss | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYu Tanaka
Wakayama Medical University Hospital
Outcome results
None listed