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Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial
- Source :
- The Lancet, 397(10289), 2070-2080. ELSEVIER SCIENCE INC
- Publication Year :
- 2021
- Publisher :
- Elsevier BV, 2021.
-
Abstract
- Background Voclosporin, a novel calcineurin inhibitor approved for the treatment of adults with lupus nephritis, improved complete renal response rates in patients with lupus nephritis in a phase 2 trial. This study aimed to evaluate the efficacy and safety of voclosporin for the treatment of lupus nephritis.Methods This multicentre, double-blind, randomised phase 3 trial was done in 142 hospitals and clinics across 27 countries. Patients with a diagnosis of systemic lupus erythematosus with lupus nephritis according to the American College of Rheumatology criteria, and a kidney biopsy within 2 years that showed class III, IV, or V (alone or in combination with class III or IV) were eligible. Patients were randomly assigned (1: 1) to oral voclosporin (23.7 mg twice daily) or placebo, on a background of mycophenolate mofetil (1 g twice daily) and rapidly tapered low-dose oral steroids, by use of an interactive web response system. The primary endpoint was complete renal response at 52 weeks defined as a composite of urine protein creatinine ratio of 0.5 mg/mg or less, stable renal function (defined as estimated glomerular filtration rate [eGFR] >= 60 mL/min/1.73 m(2) or no confirmed decrease from baseline in eGFR of >20%), no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for 3 or more consecutive days or for 7 or more days during weeks 44 through 52, just before the primary endpoint assessment. Safety was also assessed. Efficacy analysis was by intention-to-treat and safety analysis by randomised patients receiving at least one dose of study treatment. The trial is registered with ClinicalTrials.gov, NCT03021499.Findings Between April 13, 2017, and Oct 10, 2019, 179 patients were assigned to the voclosporin group and 178 to the placebo group. The primary endpoint of complete renal response at week 52 was achieved in significantly more patients in the voclosporin group than in the placebo group (73 [41%] of 179 patients vs 40 [23%] of 178 patients; odds ratio 2.65; 95% CI 1.64-4.27; p
- Subjects :
- Adult
Male
medicine.medical_specialty
Calcineurin Inhibitors
Lupus nephritis
Renal function
030204 cardiovascular system & hematology
Placebo
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Double-Blind Method
Prednisone
Internal medicine
medicine
Clinical endpoint
Humans
Lupus Erythematosus, Systemic
030212 general & internal medicine
Glucocorticoids
Aged
business.industry
General Medicine
Middle Aged
Mycophenolic Acid
medicine.disease
Lupus Nephritis
Rheumatology
Voclosporin
Calcineurin
Treatment Outcome
chemistry
Creatinine
Cyclosporine
Female
business
Glomerular Filtration Rate
medicine.drug
Subjects
Details
- ISSN :
- 01406736
- Volume :
- 397
- Database :
- OpenAIRE
- Journal :
- The Lancet
- Accession number :
- edsair.doi.dedup.....37169b55e17fa89da40d8dbbcb5072d4