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PEARL: Abetimus Sodium in SLE Renal Flare
NCT00035308Phase 3
Key facts
- Status
- Completed
- Countries
- 10
- Modality
- Antisense DNA, Small Interfering RNA (siRNA), MicroRNA (miRNA)
- Drugs
- abetimus sodium
- Conditions
- systemic lupus erythematosus (SLE)lupus nephritis (LN)
01
Overview
Phase 3, randomised, double-blind trial in systemic lupus erythematosus (SLE) and lupus nephritis (LN) comparing Abetimus Sodium with Placebo (2 arms). Primary endpoint: Time to renal flare. Status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Abetimus Sodium
Abetimus sodium 100 mg/week + Standard of Care
Placebo
Placebo + Standard of Care
03
Who it enrols
Patients with SLE, a history of renal disease, and elevated anti-dsDNA antibodies, weighing at least 40 kg. Patients with active renal disease or recent use of certain high-dose therapies are excluded.
04
Endpoints
Primary
Time to renal flare
Secondary
Number of renal flares
Time to initiation of high-dose corticosteroid and/or cyclophosphamide treatment
Major SLE flare
Anti-dsDNA antibody levels
Complement C3 levels
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