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Aurinia Renal Response in Active Lupus With Voclosporin (AURORA)

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ClinicalTrials.gov Identifier: NCT03021499
Recruitment Status : Active, not recruiting
First Posted : January 16, 2017
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

Brief Summary:
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.

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

Detailed Description:
The aim of the current study is to investigate whether voclosporin, added to the standard of care treatment in active lupus nephritis (LN), is able to reduce disease activity over a treatment period of 52 weeks. The background therapy will be MMF and initial treatment with IV methylprednisolone, followed by a reducing course of oral corticosteroids. Subjects with active, flaring LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria (as measured by urine protein/creatinine ratio (UPCR)) while demonstrating an acceptable safety profile.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. The number of subjects achieving renal response [ Time Frame: 52 Weeks ]
    The number of subjects achieving renal response


Secondary Outcome Measures :
  1. Time to UPCR of ≤0.5 mg/mg. [ Time Frame: 52 Weeks ]
    Time to UPCR of ≤0.5 mg/mg.

  2. Partial renal response [ Time Frame: Weeks 24 and 52 ]
    Partial renal response

  3. Time to 50% reduction in UPCR from baseline. [ Time Frame: 52 Weeks ]
    Time to 50% reduction in UPCR from baseline.

  4. Renal response at Week 52 [ Time Frame: 52 Weeks ]
    Renal response at Week 52

  5. Duration of renal response [ Time Frame: 52 Weeks ]
    Duration of renal response

  6. Change from baseline in laboratory parameters at each time point [ Time Frame: 52 Weeks ]
    Change from baseline in laboratory parameters at each time point

  7. Renal response with low-dose steroids [ Time Frame: 52 Weeks ]
    Renal response with low-dose steroids

  8. Quality of Life questionnaires [ Time Frame: Weeks 12, 24 and 52 ]
    Quality of Life questionnaires

  9. Change from baseline in the SELENA-SLEDAI Index score [ Time Frame: Weeks 24 and 52 ]
    Change from baseline in the SELENA-SLEDAI Index score



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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

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.

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): NCT03021499


  Show 187 Study Locations
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
Investigators
Principal Investigator: Mary Anne Dooley, MD, MPH University of North Carolina

Publications of Results:
Other Publications:
Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03021499     History of Changes
Other Study ID Numbers: AUR-VCS-2016-01
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 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:
Lupus Nephritis
Lupus Erythematosus, Systemic
Nephritis
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