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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02141672
• Date of registration: 14/05/2014
• Prospective Registration: Yes
• Primary sponsor: Aurinia Pharmaceuticals Inc.
• Public title: AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV) AURA-LV
• Scientific title: A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg BID, or 39.5 mg BID) With Placebo in Achieving Remission in Patients With Active Lupus Nephritis
• Date of first enrolment: June 2014
• Target sample size: 265
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02141672
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bangladesh, Belarus, Bulgaria, China, Ecuador, Georgia, Guatemala, Korea, Republic of, Mexico, Philippines, Poland, Russian Federation, Serbia, Singapore, Spain, Sri Lanka, Taiwan, Thailand, Ukraine, United States

Contacts

• Name: Mary Anne Dooley, MD, MPH
• Affiliation: University of North Carolina, Chapel Hill

Key inclusion & exclusion criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Intervention(s)

Drug: Placebo

Drug: Voclosporin Low Dose

Drug: Voclosporin High Dose

Primary Outcome(s)

The number of subjects achieving complete remission at 24 Weeks [Time Frame: 24 weeks]

Secondary Outcome(s)

Change from baseline in serum creatinine, urine protein, serum albumin, eGFR at each visit measured. [Time Frame: 50 Weeks]

Complete remission at 48 weeks [Time Frame: 48 Weeks]

Duration of complete remission (in months) [Time Frame: 48 Weeks]

Complete remission as per the primary endpoint analyzed at Week 48 compared to placebo in subjects with active lupus nephritis. [Time Frame: Week 48]

Proportion of subjects with active urinary sediment at each visit measured. [Time Frame: 50 Weeks]

Change from baseline in immunology parameters (C3, C4, and anti-double-stranded deoxyribonucleic acid (dsDNA) and biomarkers at each visit measured. [Time Frame: 50 Weeks]

Change from baseline in UPCR at Weeks 24 and 48. [Time Frame: Weeks 24 and 48]

Partial remission [Time Frame: Weeks 24 and 48]

Time to complete remission [Time Frame: 48 weeks]

Time to partial remission [Time Frame: 48 Weeks]

Change from baseline in the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - SLEDAI score at Weeks 24 and 48. [Time Frame: Weeks 24 and 48]

Time to (and proportion achieving) early, sustained complete remission [Time Frame: 24 Weeks]

Time to (and proportion achieving) early, sustained partial remission [Time Frame: 48 Weeks]

Time to sustained partial remission [Time Frame: 48 Weeks]

Complete remission in the presence of low dose steroids at Week 24 and Week 48. [Time Frame: Weeks 24 and 48]

Secondary ID(s)

AUR-VCS-2012-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors