drugset / Trial / NCT04536181
Study of Initial Steroid Treatment in Young Children With Nephrotic Syndrome
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.
Timeline
- Start
- 2021-01-01
- Primary completion
- 2022-09-01
- Completion
- 2022-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prednisolone | Other / unclassified | — | — |