Multicenter, randomized, open clinical study to evaluate efficacy and safety of Calcineurin inhibitors versus Mycophenolate in pediatric steroid-resistant nephrotic syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007983

Enrollment

140

Registered

2022-12-08

Start date

2022-12-01

Completion date

Unknown

Last updated

2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : A. CNI monotherapy: use tacrolimus -Start Tacrolimus 0.1-0.2 mg/kg/d (max 5mg/d, divided 2 times a day), and adjust the dosage 10-20% according to serum tacrolimus through level (target 4-8 ng/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: More than 2 years old and under the 16 years old, From Cohort of Korean pediatric nephrotic syndrome Patients who did not get the remission, by steroid (for initial 4 weeks) and CNI (for next 3 months)

Exclusion criteria

Exclusion criteria: - Patients who were used secondary immunosuppressants (CPM, MMF, RTX, levamisole, mizoribin) for nephrotic syndrome within 4 weeks - Secondary nephrotic syndrome - Low C3 (< 60mg/dL) - Patients who confirmed as genetic mutation associated with proteinuria or nephrotic syndrome

Design outcomes

Primary

Measure	Time frame
The remission rate	—

Secondary

Measure	Time frame
The complications of medication	—

Countries

Korea, Republic of

Contacts

Public ContactJeesu Min

Seoul National University Hospital

jeesu.min@gmail.com+82-2-2072-1826

Outcome results