drugset / Trial / NCT06635720

REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE)

NCT06635720

Phase 3 Active not recruiting 50 enrolled The Hospital for Sick Children
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a pilot feasibility study for a proposed full-scale randomized controlled trial to evaluate the effectiveness and safety of a reduced-dose oral prednisone (steroids) regimen to treat childhood steroid-sensitive nephrotic syndrome relapses versus standard-dose prednisone (i.e., usual standard of care). This internal pilot study is a single-center, open-label, randomized controlled trial at The Hospital for Sick Children (Toronto, ON, Canada). The primary objective of this pilot study is to determine the feasibility, safety, and resources needed to conduct the future full-scale randomized controlled trial.

Timeline

Start
2024-11-01
Primary completion
2026-02-16
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisone Other / unclassified 0.66 mg/kg Oral
Subject Prednisone Other / unclassified 1.5 mg/kg Oral
Subject Prednisone Other / unclassified 20 mg/m2 Oral
Subject Prednisone Other / unclassified 40 mg/m2 Oral