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Trial record 91 of 146 for:    lupus AND Lupus Nephritis

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.

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).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Voclosporin Drug: Placebo Oral Capsule Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AURORA 2: Aurinia Renal Response in Lupus With Voclosporin
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Voclosporin
Voclosporin
Drug: Voclosporin
Calcineurin inhibitor, oral, 23.7 mg BID
Other Name: ISA247

Placebo Comparator: Placebo Oral Capsule
Placebo
Drug: Placebo Oral Capsule
Voclosporin placebo, oral, 3 capsules BID




Primary Outcome Measures :
  1. Adverse events (AE) profile and routine biochemical and hematological assessments. [ Time Frame: 36 months ]
    Adverse events (AE) profile and routine biochemical and hematological assessments.


Secondary Outcome Measures :
  1. Proportion of subjects in renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]
    Proportion of subject in renal response

  2. Proportion of subjects in partial renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]
    50% reduction in baseline UPCR.

  3. Renal flare as adjudicated by the Clinical Endpoints Committee (CEC). [ Time Frame: Up to 37 months ]
    Renal flare and extra-renal flare

  4. 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.

  5. 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.

  6. Change in estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.

  7. Change in urine protein [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.

  8. Change in serum creatinine [ Time Frame: Up to 37 months ]
    Change from AURORA 1 baseline.

  9. Change in immunology (Complement 3 (C3)) parameters from AURORA 1 baseline. [ Time Frame: Up to 37 months ]
    Complement C3: mg/dL

  10. Change in immunology parameters (complement 4 (C4)) from AURORA 1 baseline. [ Time Frame: Up to 37 months ]
    Complement C4: mg/dL

  11. 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

  12. 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.

  13. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597464


Contacts
Contact: Antonia Coeshall 441962715493 acoeshall@auriniapharma.com
Contact: Laura Lisk 44(0)7790555604 llisk@auriniapharma.com

Locations
United States, Oklahoma
AURORA Investigative Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.

Publications:

Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03597464     History of Changes
Other Study ID Numbers: AUR-VCS-2016-02
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aurinia Pharmaceuticals Inc.:
lupus nephritis
calcineurin inhibitors
voclosporin

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Calcineurin Inhibitors
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents