Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)

Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06) - Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome in children: A randomized controlled trial (JSRDC06)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000379

Enrollment

Registered

2006-04-01

Start date

2001-04-01

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

Interventions

prednisolone mizoribine+prednisolone

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL). 2.Patients with treatment either based on the International study of kidney disease in children (ISKDC) or similar to ISKDC. 3.Steroid-sensitive nephrotic syndrome in first onset. 4.First replase happended within 6 mounths after first onset. 5.Aged twelve months to 18 years. 6.Written informed consent from the patients' parents or legal guardians.

Exclusion criteria

Exclusion criteria: 1.History of relapse. 2.Medical history of allergy or hypersensitivity reactions to mizoribine. 3.Poorly controlled hypertension. 4.Chronic renal dysfunction. 5.Active infectious disease. 6.Severe liver disfunction. 7.History of saireito and immunosupression administration. 8.Pregnancy. 9.Judged inappropriate for this study by the physicians.

Design outcomes

Primary

Measure	Time frame
Relapse-free period	—

Countries

Japan

Outcome results

None listed

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