NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000379

Registered date:01/04/2006

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)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedSteroid-sensitive nephrotic syndrome
Date of first enrollment2001/04/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)prednisolone mizoribine+prednisolone

Outcome(s)

Primary OutcomeRelapse-free period
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum1years-old
Age maximum10years-old
GenderMale and Female
Include criteria
Exclude criteria1.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.

Related Information

Contact

public contact
Name
Address Japan
Telephone
E-mail
Affiliation Japanese Study Group of Renal Disease in Children(JSRDC) Department of Nephrology,Tokyo Metropolitan Children's Hospital
scientific contact
Name Norishige Yosikawa
Address 811-1 Kimiidera Wakayama City Wakayama Japan
Telephone
E-mail
Affiliation Wakayama Medical University Department of Pediatrics