Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Acthar Gel for Drug Resistant Nephrotic Syndrome in Children
NCT03408405Phase 4
Key facts
- Status
- Withdrawn
- Start
- Jun 2018
- Primary completion
- Jan 2021
- Sponsor
- Rhode Island Hospital
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- nephrotic syndrome
01
Overview
Phase 4, open-label, single-arm trial of repository corticotropin injection in nephrotic syndrome, sponsored by Rhode Island Hospital. Primary endpoint: Remission of proteinuria at 18 months. Planned start Jun 2018; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Acthar Gel treatment group
Acthar Gel 80 units/1.73 m2 SQ twice a week for 6 months.
03
Who it enrols
Children 2-21 years with steroid-resistant nephrotic syndrome (failed 12 weeks of prednisone or other agent), eGFR > 50, and specific biopsy findings. Excludes genetic forms of NS, diabetes, and severe hypertension.
04
Endpoints
Primary
Remission of proteinuria
Secondary
Blood pressure
Serum Creatinine
Body Mass Index
Serum Glucose
Serum Lipids
Pediatric Quality of Life Inventory, ESRD, Acute Version
Beyond the preview
Go deeper on NCT03408405.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03408405.