Aurinia Renal Response in Active Lupus With Voclosporin

Completed · Phase 3 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

Key facts

Study ID

NCT03021499

Run by

Aurinia Pharmaceuticals Inc.

People needed

358

Starts

2017-05-17

Expected to finish

2019-10-10

Last updated by the study team

2023-03-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• AURORA Investigative Center — Phoenix, Arizona, United States
• AURORA Investigative Center — Phoenix, Arizona, United States
• AURORA Investigative Center — Beverly Hills, California, United States
• AURORA Investigative Center — Los Angeles, California, United States
• AURORA Investigative Center — Los Angeles, California, United States
• AURORA Investigative Center — Palo Alto, California, United States
• AURORA Investigative Center — Thousand Oaks, California, United States
• AURORA Investigative Center — Torrance, California, United States
• AURORA Investigative Center — Aurora, Colorado, United States
• AURORA Investigative Center — Denver, Colorado, United States
• AURORA Investigative Center — New Haven, Connecticut, United States
• AURORA Investigative Center — Clearwater, Florida, United States
• AURORA Investigative Center — DeBary, Florida, United States
• AURORA Investigative Center — Fort Lauderdale, Florida, United States
• AURORA Investigative Center — Fort Myers, Florida, United States
• AURORA Investigative Center — Miami, Florida, United States
• AURORA Investigative Center — Orlando, Florida, United States
• AURORA Investigative Center — Winter Park, Florida, United States
• AURORA Investigative Center — Atlanta, Georgia, United States
• AURORA Investigative Center — Columbus, Georgia, United States
• AURORA Investigative Center — Lawrenceville, Georgia, United States
• AURORA Investigative Center — Chicago, Illinois, United States
• AURORA Investigative Center — Louisville, Kentucky, United States
• AURORA Investigative Center — Baton Rouge, Louisiana, United States
• AURORA Investigative Center — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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