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Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2)

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ClinicalTrials.gov Identifier: NCT03597464
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE June 25, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE June 12, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Adverse events (AE) profile and routine biochemical and hematological assessments. [ Time Frame: 36 months ]
Adverse events (AE) profile and routine biochemical and hematological assessments.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • Proportion of subjects in renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]
    Proportion of subject in renal response
  • Proportion of subjects in partial renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]
    50% reduction in baseline UPCR.
  • Renal flare as adjudicated by the Clinical Endpoints Committee (CEC). [ Time Frame: Up to 37 months ]
    Renal flare and extra-renal flare
  • Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) [ Time Frame: Months 18, 24 and 36 ]
    Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of <2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity.
  • Change in Urine Protein to Creatinine Ratio (UPCR) [ Time Frame: Up to 37 months ]
    Change from Aurinia Renal Response in Active Lupus With Voclosporin (AURORA) 1 baseline.
  • Change in estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.
  • Change in urine protein [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.
  • Change in serum creatinine [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.
  • Change in immunology (Complement 3 (C3)) parameters from AURORA 1 baseline. [ Time Frame: Up to 37 months ]
    Complement C3: mg/dL
  • Change in immunology parameters (complement 4 (C4)) from AURORA 1 baseline. [ Time Frame: Up to 37 months ]
    Complement C4: mg/dL
  • Change in immunology parameters (anti-double-stranded deoxyribonucleic acid) from AURORA 1 baseline. [ Time Frame: Up to 37 months ]
    Anti-double stranded DNA: IU/mL
  • Change Health Related Quality of Life Assessments (HRQoL) Short Form Health Survey (SF-36) [ Time Frame: Months 18,24,30,36 ]
    A set of 36 generic questions assessing quality of life and health status across 8 health concepts (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions) and is reliant upon patient self-reporting.
  • Healthcare Resource Utilization (HRU) [ Time Frame: Months 12, 15, 18, 21, 24, 27, 30, 33, 36 ]
    Qualitative information gathered form the subjects via interview related to utilisation of healthcare resources e.g visits to health care practitioners
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • Proportion of subjects in renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]
    Proportion of subject in renal response
  • Proportion of subjects in partial renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]
    50% reduction in baseline UPCR.
  • Renal flare as adjudicated by the Clinical Endpoints Committee (CEC). [ Time Frame: Up to 37 months ]
    Renal flare and extra-renal flare
  • SELENA-SLEDAI scores [ Time Frame: Months 18, 24 and 36 ]
    Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI scores). Assessment of disease activity- scoring of twenty four items for 9 organ systems and summed to a maximum of 105 points (higher scores indicated worse disease activity).
  • Change in UPCR [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.
  • Change in eGFR [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.
  • Change in urine protein [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.
  • Change in serum creatinine [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.
  • Change in immunology parameters from AURORA 1 baseline. [ Time Frame: Up to 37 months ]
    Complement 3 (C3), complement 4 (C4), and anti-double-stranded deoxyribonucleic acid (DNA)
  • Change in HRQOL (SF36) from AURORA 01 Baseline [ Time Frame: Months 18,24,30,36 ]
    Health Related Quality of Life Assessments (HRQoL) Short Form Health Survey (SF-36) - 36-question subject questionnaire assessing impact of health on daily activities.
  • Healthcare Resource Utilization (HRU) [ Time Frame: Months 12, 15, 18, 21, 24, 27, 30, 33, 36 ]
    Qualitative information gathered form the subjects via interview related to utilisation of healthcare resources e.g visits to health care practitioners
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
Official Title  ICMJE AURORA 2: Aurinia Renal Response in Lupus With Voclosporin
Brief Summary The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).
Detailed Description The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of MMF and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lupus Nephritis
Intervention  ICMJE
  • Drug: Voclosporin
    Calcineurin inhibitor, oral, 23.7 mg BID
    Other Name: ISA247
  • Drug: Placebo Oral Capsule
    Voclosporin placebo, oral, 3 capsules BID
Study Arms  ICMJE
  • Experimental: Voclosporin
    Voclosporin
    Intervention: Drug: Voclosporin
  • Placebo Comparator: Placebo Oral Capsule
    Placebo
    Intervention: Drug: Placebo Oral Capsule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2018)
227
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
  2. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
  3. Subject is willing to continue taking oral MMF for the duration of the study.

Exclusion Criteria:

  1. Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
  2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
  3. A planned kidney transplant within study treatment period.
  4. Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
  5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
  6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antonia Coeshall 441962715493 acoeshall@auriniapharma.com
Contact: Laura Lisk 44(0)7790555604 llisk@auriniapharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03597464
Other Study ID Numbers  ICMJE AUR-VCS-2016-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aurinia Pharmaceuticals Inc.
Study Sponsor  ICMJE Aurinia Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aurinia Pharmaceuticals Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP