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Completed

NCT Number: NCT03597464

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

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).

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

AURORA Investigative Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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 mycophenolate mofetil (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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Written informed consent before any study-specific procedures were performed.
  • In the opinion of the investigator, subject required continued immunosuppressive therapy.
  • Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
  • Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study.

Exclusion criteria

  • 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.
  • Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
  • A planned kidney transplant within study treatment period.
  • 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.
  • Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
  • Vaccines using live organisms, virus or bacterial, while taking the study treatment.

Treatment and study plan

voclosporin

Drug

Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)

Other names: ISA247

Placebo oral capsule

Drug

Voclosporin placebo, oral, 3 capsules twice daily (BID)

Primary outcomes

  1. Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.

    Time frame: Month 12 (AURORA 2 baseline) to Month 36

    Number (and percent) of adverse events experienced during the AURORA 2 treatment period.

    To 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 LN.

Secondary outcomes

  1. Number (and Percent) of Subjects in Renal Response

    Time frame: Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36

    Proportion of subjects in renal response defined as:

    • urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg
    • estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m^2 or no confirmed decrease from baseline in eGFR of >20%
    • Received no rescue medication for LN
    • Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during the 8 weeks prior to the renal response assessment.

  2. Number (and Percent) of Subjects in Partial Renal Response

    Time frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

    Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR).

  3. Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC).

    Time frame: Month 12 (AURORA 2 baseline) to Month 36

    A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria:

    • A reproducible increase to UPCR >1 mg/mg from a post-response baseline of <0.2 mg/mg or
    • an increase to UPCR >2 mg/mg from a post-response baseline between 0.2 to 1.0 mg/mg or
    • a doubling of UPCR for baseline values of UPCR >1 mg/mg

  4. Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)

    Time frame: Months 18, 24 and 36

    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

    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 From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR)

    Time frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

    Reductions in UPCR are indicative of better renal outcomes.

  6. Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

    This endpoint incorporated Corrected eGFR values with a ceiling set to 90 mL/min/1.73 m^2

    Increases in eGFR levels are indicative of better renal outcomes.

  7. Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein

    Time frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

    Reductions in Urine Protein levels are indicative of better renal outcomes.

  8. Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr)

    Time frame: Months 12 (AURORA 2 baseline), 18, 24, 30 and 36

    Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2.

    Decreases in SCr levels can be indicative of better renal outcomes.

Sponsors and collaborators

Lead sponsor

Aurinia Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis

Acronym: AURORA 2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2018
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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