Aurinia Renal response in Active Lupus with Voclosporin (AURORA)

Phase 3

Completed

• Conditions: upus Nephritis

• Registration Number: JPRN-jRCT2080223765
• Lead Sponsor: Aurinia Pharmaceuticals Inc./ CMIC Co., Ltd.

Brief Summary

Treatment with voclosporin resulted in a clinically meaningful and statistically significant higher renal response rate compared to placebo when given with MMF and steroids; the odds of achieving renal response were greater for voclosporin versus placebo (OR 2.65; 95% CI: 1.64, 4.27; p<0.001). Treatment benefit of voclosporin was seen in all pre-specified subgroups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-09
• Study Completion: 2019-10-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

Key Inclusion Criteria
Subjects with evidence of active nephritis, defined as follows:
Kidney biopsy result within 2 years prior to screening indicating Class III, IV S, IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater increase of urine protein creatinine ratio (UPCR) within the last 6 months to a minimum of >=1.5 mg/mg for Class III/IV or to a minimum of >=2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility.
OR
Kidney biopsy result within 6 months prior to screening indicating Class III, IV S, or IV-G (alone or in combination with Class V) LN with a UPCR of >=1.5 mg/mg at screening.
OR
Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of >=2 mg/mg at screening.
A biopsy can be performed during screening, if not available. The above criteria must be fulfilled at baseline.

Exclusion Criteria

Estimated glomerular filtration rate (eGFR) of =<45 mL/minute at screening.
Current or medical history of:
-Congenital or acquired immunodeficiency.
-In the opinion of the investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
-Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision.
-Lymphoproliferative disease or previous total lymphoid irradiation.
-Severe viral infection or known HIV infection.
-Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
Other known clinically significant active medical conditions, such as:
-Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified