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

NCT ID: NCT03597464

Last Updated: 2022-12-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-29

Study Completion Date

2021-10-07

Brief Summary

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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

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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.

Conditions

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Lupus Nephritis

Keywords

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lupus nephritis calcineurin inhibitors voclosporin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Voclosporin

Voclosporin

Group Type EXPERIMENTAL

Voclosporin

Intervention Type DRUG

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

Placebo Oral Capsule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type DRUG

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

Interventions

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Voclosporin

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

Intervention Type DRUG

Placebo Oral Capsule

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

Intervention Type DRUG

Other Intervention Names

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ISA247

Eligibility Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aurinia Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AURORA Investigative Center

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

References

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Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM, Hooi LS, Brunetta P, Maciuca R, Solomons N. Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice? Clin J Am Soc Nephrol. 2013 Jan;8(1):147-53. doi: 10.2215/CJN.03290412. Epub 2012 Aug 9.

Reference Type BACKGROUND
PMID: 22879439 (View on PubMed)

Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.

Reference Type BACKGROUND
PMID: 22087680 (View on PubMed)

Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309.

Reference Type BACKGROUND
PMID: 24330024 (View on PubMed)

Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8.

Reference Type BACKGROUND
PMID: 23996158 (View on PubMed)

Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4.

Reference Type BACKGROUND
PMID: 23736966 (View on PubMed)

Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.

Reference Type BACKGROUND
PMID: 21943027 (View on PubMed)

Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.

Reference Type DERIVED
PMID: 37528520 (View on PubMed)

Provided Documents

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Document Type: Study Protocol: Protocol v1.0

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Document Type: Study Protocol: Protocol v2.0

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Document Type: Study Protocol: Protocol v3.0

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Document Type: Statistical Analysis Plan

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Other Identifiers

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AUR-VCS-2016-02

Identifier Type: -

Identifier Source: org_study_id