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SABINE - The efficacy and Safety of delayed-release Budesonide in children with primary IgA nephropathy - a multicenter, interventional phase III, randomized, placebo-controlled, double-blind study.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518759-45-00
Acronym
SABINE/01/2022
Enrollment
120
Registered
2025-06-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-25

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

Conditions

Children primary nephropathy IgA

Brief summary

Reduction of UPCR after 24 weeks of treatment, Assessment of the percentage change in proteinuria at the end of treatment compared to the beginning of treatment

Detailed description

Number of side effects., Reduction in GFR during treatment, Reduction of UPCR after 24 weeks of treatment in relation to the beginning of treatment (deltaUPCR)

Interventions

DRUGEncorton
DRUG5 mg
DRUGtabletki
DRUG1 mg
DRUGEntocort
DRUG3 mg
DRUGkapsułki o przedłużonym uwalnianiu
DRUGtwarde
DRUGPlacebo Prednisone/Budesonide

Sponsors

Medical University Of Warsaw
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Reduction of UPCR after 24 weeks of treatment, Assessment of the percentage change in proteinuria at the end of treatment compared to the beginning of treatment—

Secondary

MeasureTime frame
Number of side effects., Reduction in GFR during treatment, Reduction of UPCR after 24 weeks of treatment in relation to the beginning of treatment (deltaUPCR)—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026