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A multi-center randomized controlled trial Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing steroid sensitive nephrotic syndrome in children (JSKDC05)

A multi-center randomized controlled trial Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing steroid sensitive nephrotic syndrome in children (JSKDC05) - A RCT Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing SSNS in children (JSKDC05)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005103
Enrollment
120
Registered
2011-03-01
Start date
2011-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Steroid sensitive nephrotic syndrome in children

Interventions

A: Standard Prednisolone therapy B: Standard Prednisolone therapy + High-dose Mizoribine

Sponsors

Japanese Study Group of Kidney Disease in Children
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)The initial episode of idiopathic nephrotic syndrome (2)Treated with PSL therapy based on the International study of kidney disease and Diagnosed first relapse within 6 months when remission at first episode was confirmed (3)Aged two years under 11 years (4)Diagnosis of steroid sensitive has been performed within the third week after the onset of PSL therapy against first relapse (5)Patient will be able to go to hospital during therapy (6)Written informed consent from the patients' parents or legal guardians

Exclusion criteria

Exclusion criteria: (1)Other renal nephrotic syndrome(persistent hematuria) (2)History of Henoch-Schönlein nephritis, systemic lupus erythematosus or secondary nephrotic syndrome (3)History of steroid resistant (4)History of immunosuppressants administration against nephrotic syndrome (5)Uncontrollable hypertension (6)Renal dysfunction(creatinine clearance < 90 mL/min) (7)Severe liver dysfunction (8)Patients enrolling another clinical trials at the first relapse (9)Judged inappropriate for this study by the physicians

Design outcomes

Primary

MeasureTime frame
Time to frequent relapse

Countries

Japan

Contacts

Public ContactYuko Shima

Wakayama Medical University Department of Pediatrics

jskdc@wakayama-med.ac.jp073-441-0633

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026