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Baricitinib vs MMF for Maintaining Lupus Nephritis Remission
NCT05686746Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2022
- Primary completion
- Jun 2023
- Countries
- 1
- Sponsor
- Assiut University
- Modality
- Recombinant Proteins and Enzymes, Small Molecules, Antibody-Based Therapeutics
- Drugs
- baricitinib
- Conditions
- lupus nephritis (LN)
01
Overview
Phase 3, randomised trial of baricitinib in lupus nephritis (LN) (3 arms), sponsored by Assiut University. Primary endpoint: Protein Creatinine Ratio at 1 year. Status: unknown.
02
Design
3 arms- Study design
- Randomized
Baricitinib 4 mg
Baricitinib 4 mg oral tablet daily
Baricitinib 2 mg
Baricitinib 2 mg oral tablet daily
MMF
Mycophenolate Mofetil 1000 mg daily (500 mg twice daily)
03
Who it enrols
Patients with a clinical diagnosis of Lupus nephritis in remission, able to swallow tablets. Excludes patients with antiphospholipid syndrome, history of thrombosis, severe anemia, leukopenia, thrombocytopenia, or impaired liver and renal function.
04
Endpoints
Primary
Protein Creatinine Ratio
Secondary
Complement Component 3
Anti-double stranded DNA Antibody
Antinuclear Antibody
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