High-dose mizoribine with prednisolone therapy

JRCT ID: jRCTs071180060

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Nephrotic syndrome
• Date of first enrollment: 06/06/2011
• Target sample size: 120
• Study type: Interventional
• Intervention(s): High-dose mizoribine with prednisolone therapy

Outcome(s)

• Primary Outcome: Duration 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
• Gender: Both

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

• Primary Sponsor: Nakanishi Koichi
• Secondary Sponsor: Iijima Kazumoto
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare Scientific Research Grant
• Secondary ID(s): UMIN000005103