Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children: A Multi-center randomized controlled trial

Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children: A Multi-center randomized controlled trial - Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children(JSKDC04)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000747

Enrollment

250

Registered

2007-09-01

Start date

2007-09-01

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

Idiopatic nephrotic syndrome in children

Interventions

PSL for 2 months PSL for 6 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The first episode of idiopathic nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL). 2)Treated with predonisolone 60 mg/m2/day single daily dosing for 4 weeks. 3)Diagnosis of steroid sensitive NS has been performed within within the third week after the onset of PSL therapy. 4)Aged twelve months to 15 years. 5)Written informed consent from the patients' parents or legal guardians.

Exclusion criteria

Exclusion criteria: 1)Other renal nephrotic syndrome(IgA nephropathy) 2)Henoch-Sch&ouml;nlein nephritis, systemic lupus erythematosus 3)History of immunosuppressant administration. 4)Poorly controlled hypertension. 5)Renal dysfunction(creatinine clearance < 60 mL/min). 6)Active infectious disease. 7)Severe liver disfunction. 8)Pregnancy. 9)Judged inappropriate for this study by the physicians.

Design outcomes

Primary

Measure	Time frame
Time to frequent relapse	—

Countries

Japan

Contacts

Public ContactNakanishi

Japanese Study Group of Kidney Disease in Children Department of Pediatrics, Wakayama Medical University

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

Outcome results

None listed

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