AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.

Key facts

Study ID

NCT02141672

Run by

Aurinia Pharmaceuticals Inc.

People needed

265

Starts

2014-06-01

Expected to finish

2017-01-01

Last updated by the study team

2021-05-18

Who can join

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

You may qualify if…

• Male or female subjects aged 18 to 75 years.
• Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria.
• Kidney biopsy within 6 months prior to Screening (Visit 1) with a histologic diagnosis of lupus nephritis (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis) Classes III, IV-S or IV-G, (A) or (A/C); or Class V, alone or in combination with Class III or IV.
• Laboratory evidence of active nephritis at screening, defined as:
• Class III, IV-S or IV-G: Confirmed proteinuria ≥1,500 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥1.5 mg/mg assessed in a first morning void urine specimen (2 samples).
• Class V (alone or in combination with Class III or IV): Confirmed proteinuria ≥2,000 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥2 mg/mg assessed in a first morning void urine specimen (2 samples).

You may not qualify if…

• Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2.
• Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• A previous kidney transplant or planned transplant within study treatment period.
• In the opinion of the Investigator, subject does not require long-term immunosuppressive treatment (in addition to corticosteroids).
• Current or medical history of:
• Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.
• Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be randomized.
• Congenital or acquired immunodeficiency.
• Clinically significant drug or alcohol abuse 2 years prior to screening.
• Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat PAP are allowed.
• Lymphoproliferative disease or previous total lymphoid irradiation.
• Severe viral infection (such as CMV, HBV, HCV) within 3 months of screening; or known human immunodeficiency virus 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 including congestive heart failure, history of cardiac dysrhythmia or congenital long QT syndrome.
• Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than 2.5 times the upper limit of normal) at screening and confirmed before randomization.
• Chronic obstructive pulmonary disease or asthma requiring oral steroids.
• Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count <2,500/mm3; absolute neutrophil count <1.3 x 103/μL; thrombocytopenia (platelet count <50,000/mm3).
• Active bleeding disorders.
• Current infection requiring IV antibiotics.
• Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes. Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes are not excluded.
• Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.

Where it is running

• AURA-LV Site — Palo Alto, California, United States
• AURA-LV Site — Gainesville, Florida, United States
• AURA-LV Site — Miami, Florida, United States
• AURA-LV Site — Farmington Hills, Michigan, United States
• AURA-LV Site — Brooklyn, New York, United States
• AURA-LV Site — New York, New York, United States
• AURA-LV Site — Chapel Hill, North Carolina, United States
• AURA-LV Site — Charlotte, North Carolina, United States
• AURA-LV Site — Columbus, Ohio, United States
• AURA-LV Site — Hershey, Pennsylvania, United States
• AURA-LV Site — Chattanooga, Tennessee, United States
• AURA-LV Site — Dallas, Texas, United States
• AURA-LV Site — Houston, Texas, United States
• AURA-LV Site — Dhaka, Bangladesh
• AURA-LV Site — Dhaka, Bangladesh
• AURA-LV Site — Minsk, Belarus
• AURA-LV Site — Minsk, Belarus
• AURA-LV Site — Minsk, Belarus
• AURA-LV Site — Vitebsk, Belarus
• AURA-L Site — Plovdiv, Bulgaria
• AURA-LV Site — Sofia, Bulgaria
• AURA-LV Site — Sofia, Bulgaria
• AURA-LV Site — Varna, Bulgaria
• AURA-LV Site — Hong Kong, China
• AURA-LV Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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