High-dose mizoribine with prednisolone therapy

Phase 3

• Conditions: ephrotic syndrome; D009404

• Registration Number: JPRN-jRCTs071180060
• Lead Sponsor: akanishi Koichi

Brief Summary

Overall, the results of the mizoribine combination were better than those of the standard treatment group, confirming its efficacy. Infections occurred more frequently in the high-dose mizoribine group, but there were no deaths or serious adverse events, and safety was acceptable.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-19
• Study Completion: 2020-11-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 88

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified