Aurinia Renal Response in Active Lupus With Voclosporin

• Register: ClinicalTrials.gov
• Last refreshed on: 3 April 2023
• Main ID: NCT03021499
• Date of registration: 12/01/2017
• Prospective Registration: Yes
• Primary sponsor: Aurinia Pharmaceuticals Inc.
• Public title: Aurinia Renal Response in Active Lupus With Voclosporin AURORA
• Scientific title: A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg Twice Daily) With Placebo in Achieving Renal Response in Subjects With Active Lupus Nephritis
• Date of first enrolment: May 17, 2017
• Target sample size: 358
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03021499
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Belarus, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Dominican Republic, Guatemala, Japan, Korea, Republic of, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Netherlands, North Macedonia, Peru, Philippines, Poland, Puerto Rico, Russian Federation, Serbia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States, Vietnam

Contacts

• Name: Samir Parikh, MD
• Affiliation: Ohio State University

Key inclusion & exclusion 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 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.

- Women of childbearing potential must have a negative serum pregnancy test at
screening and a negative urine pregnancy test 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.



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

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Intervention(s)

Drug: Voclosporin

Drug: Placebo Oral Capsule

Primary Outcome(s)

Number of Participants With Adjudicated Renal Response at Week 52 [Time Frame: 52 Weeks]

Secondary Outcome(s)

Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio =0.5 mg/mg) [Time Frame: Week 52]

Change From Baseline in eGFR [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.]

Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI) [Time Frame: Week 24 and Week 52]

Duration of Renal Response (Number of Days) [Time Frame: Week 52]

Time to 50% Reduction in UPCR (Number of Days) [Time Frame: 52 weeks]

Number of Participants With Renal Response at Week 24 [Time Frame: Week 24]

Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio [Time Frame: 52 Weeks]

Change From Baseline in UPCR [Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.]

Number of Subjects With Partial Renal Response at Weeks 24 & 52 [Time Frame: Weeks 24 and 52]

Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less [Time Frame: 52 Weeks]

Time to Urine Protein Creatinine Ratio of =0.5 mg/mg (Number of Days) [Time Frame: 52 Weeks]

Change From Baseline in Patient Reported Outcomes [Time Frame: Week 24 and Week 52]

Number of Subjects With Renal Response With Low Dose Steroids [Time Frame: Week 24 and Week 52]

Secondary ID(s)

AUR-VCS-2016-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03021499