NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071180060

Registered date:19/03/2019

High-dose mizoribine with prednisolone therapy

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedNephrotic syndrome
Date of first enrollment06/06/2011
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)High-dose mizoribine with prednisolone therapy

Outcome(s)

Primary OutcomeDuration from registration to diagnosis of frequently relapsing nephrotic syndrome
Secondary Outcome(1) relapse-free period (2) proportion of patients without relapses (3) number of relapses per person/year (4) time to steroid-dependent nephrotic syndrome (5) time to steroid-resistant nephrotic syndrome (6) total prednisolone dose (7) adverse events (8) serum mizoribine concentrations at trough and C3

Key inclusion & exclusion criteria

Age minimum>= 2age old
Age maximum< 11age old
GenderBoth
Include criteria(1) Patients diagnosed with a first episode of nephrotic syndrome who meet 1) urinary protein/creatinine ratio > or = 1.8 and 2) < or = 2.5 g/dL of serum albumin (2) Patients treated by the ISKDC based regimen at the first episode and relapsed within 6 months after the first remission (3) Age at the registration > or = 2 and < 11 years (4) Patients who remit within 3 weeks after PSL treatment for the first relapse
Exclude criteria(1) Patients diagnosed with nephritic nephrotic syndrome (2) Patients diagnosed with IgA vasculitis, systemic lupus nephritis or secondary nephrotic syndrome (3) Patients who have been diagnosed with steroid-resistant nephrotic syndrome (SRNS) (4) Patients who have been treated with any immunosuppressant for nephrotic syndrome (5) Patients with poorly controlled hypertension, impaired renal function, or severe liver dysfunction 6) Patients who are participating in other studies at the time of registration

Related Information

Contact

Public contact
Name Yuko Shima
Address 811-1 Kimiidera, Wakayama-city Wakayama Japan 641-0012
Telephone +81-73-441-0633
E-mail yukotk@wakayama-med.ac.jp
Affiliation Wakayama Medical University
Scientific contact
Name Koichi Nakanishi
Address 207 Uehara, Nishihara-cho, Okinawa Okinawa Japan 903-0125
Telephone +81-98-895-1154
E-mail knakanis@med.u-ryukyu.ac.jp
Affiliation Graduate School of Medicine, University of the Ryukyus