AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

NCT02141672 | Completed Phase 2 Results DMC

• 1 other identifier: AUR-VCS-2012-01
• Study Type: interventional
• Target: 265
• Locations: 20 countries
• Sites: 86

Brief Summary

To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.

Conditions

Lupus Nephritis

Keywords

lupus nephritis; calcineurin inhibitors; voclosporin

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving Complete Renal Remission at 24 Weeks

  Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.

  week 24

Secondary Outcomes (16)

• Number of Subjects Achieving Complete Renal Remission at 48 Weeks

  Week 48

• Number of Subjects Achieving Complete Renal Remission at 24 and 48 Weeks in the Presence of Low Dose Steroids

  Weeks 24 and 48

• Time to Complete Remission (Number of Weeks)

  week 48

• Time to Sustained Early Complete Remission (Number of Weeks)

  week 48

• Number of Subjects Achieving Sustained Early Complete Remission

  week 48

Study Arms (3)

Voclosporin Low Dose

EXPERIMENTAL

Voclosporin, oral, 23.7 mg BID

Drug: Voclosporin Low Dose

Voclosporin High Dose

EXPERIMENTAL

Voclosporin, oral 23.7 mg BID until Week 2, then voclosporin, oral, 39.5 mg BID

Drug: Voclosporin High Dose

Placebo

PLACEBO COMPARATOR

Low dose: Voclosporin placebo, oral, 3 capsules BID High dose: Voclosporin placebo, oral, 3 capsules BID until Week 2 then voclosporin placebo, oral, 5 capsules BID

Drug: Placebo

Interventions

Voclosporin High Dose DRUG

Also known as: ISA247

Voclosporin High Dose

Voclosporin Low Dose DRUG

Also known as: ISA247

Voclosporin Low Dose

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 to 75 years.
• Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria.
• Kidney biopsy within 6 months prior to Screening (Visit 1) with a histologic diagnosis of lupus nephritis (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis) Classes III, IV-S or IV-G, (A) or (A/C); or Class V, alone or in combination with Class III or IV.
• Laboratory evidence of active nephritis at screening, defined as:
• Class III, IV-S or IV-G: Confirmed proteinuria ≥1,500 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥1.5 mg/mg assessed in a first morning void urine specimen (2 samples).
• Class V (alone or in combination with Class III or IV): Confirmed proteinuria ≥2,000 mg/24 hours when assessed by 24 hour urine collection, defined by a UPCR of ≥2 mg/mg assessed in a first morning void urine specimen (2 samples).

You may not qualify if:

• Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2.
• Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• A previous kidney transplant or planned transplant within study treatment period.
• In the opinion of the Investigator, subject does not require long-term immunosuppressive treatment (in addition to corticosteroids).
• Current or medical history of:
• Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.
• Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be randomized.
• Congenital or acquired immunodeficiency.
• Clinically significant drug or alcohol abuse 2 years prior to screening.
• Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat PAP are allowed.
• Lymphoproliferative disease or previous total lymphoid irradiation.
• Severe viral infection (such as CMV, HBV, HCV) within 3 months of screening; or known human immunodeficiency virus 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 including congestive heart failure, history of cardiac dysrhythmia or congenital long QT syndrome.

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (86)

AURA-LV Site

Los Angeles, California, 90095, United States

Location

AURA-LV Site

Palo Alto, California, 94305, United States

Location

AURA-LV Site

Gainesville, Florida, 32610, United States

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AURA-LV Site

Miami, Florida, 33165, United States

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AURA-LV Site

Farmington Hills, Michigan, 48334, United States

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AURA-LV Site

Brooklyn, New York, 11203, United States

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AURA-LV Site

New York, New York, 10016, United States

Location

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Chapel Hill, North Carolina, 27599, United States

Location

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Charlotte, North Carolina, 28204, United States

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Columbus, Ohio, 43210, United States

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Hershey, Pennsylvania, 17033, United States

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Chattanooga, Tennessee, 37408, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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AURA-LV Site

Dhaka, 1207, Bangladesh

Location

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Dhaka, Bangladesh

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Minsk, 220037, Belarus

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Minsk, 220116, Belarus

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Minsk, 223040, Belarus

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AURA-LV Site

Vitebsk, 210037, Belarus

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AURA-L Site

Plovdiv, 4001, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1527, Bulgaria

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Varna, 9010, Bulgaria

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Hong Kong, China

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Guayaquil, Ecuador

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Quito, Ecuador

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Tbilisi, 0144, Georgia

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Tbilisi, 0186, Georgia

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Guatemala City, Guatemala

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Guadalajara, 44280, Mexico

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Mexicali, 21100, Mexico

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Oaxaca City, Mexico

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Tlalpan, 14080, Mexico

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Tlalpan, Mexico

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Angeles City, 2009, Philippines

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Batangas, 4217, Philippines

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Cebu City, 6000, Philippines

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Davao City, 8000, Philippines

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Manila, 10000, Philippines

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Manila, 1000, Philippines

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Manila, 1003, Philippines

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AURA-LV Site

Quezon City, 1102, Philippines

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AURA-LV Site

Katowice, 40-027, Poland

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Radom, 26-610, Poland

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Warsaw, 01-141, Poland

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Wroclaw, 50-556, Poland

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Kazan', 420012, Russia

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Kemerovo, 650066, Russia

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Kemerovo, 65009, Russia

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Moscow, 111539, Russia

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Moscow, 119435, Russia

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Omsk, 644111, Russia

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Orenburg, 460018, Russia

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Petrozavodsk, 185019, Russia

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AURA-LV Site

Rostov-on-Don, 344022, Russia

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Saint Petersburg, 191015, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197110, Russia

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Saratov, 410053, Russia

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Tolyatti, 445009, Russia

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Yaroslavl, 150062, Russia

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Belgrade, 11000, Serbia

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Niš, 18000, Serbia

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Singapore, 169608, Singapore

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Singapore, 529889, Singapore

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Busan, 602-739, South Korea

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AURA -LV Site

Daegu, 705-718, South Korea

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Seoul, 110-744, South Korea

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Seoul, 158-710, South Korea

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Wŏnju, 220-701, South Korea

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Barcelona, Spain

Location

AURA-LV

Madrid, 28034, Spain

Location

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Colombo, Sri Lanka

Location

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Kandy, 20000, Sri Lanka

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AURA-LV Site

Nugegoda, 10100, Sri Lanka

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Ragama, Sri Lanka

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AURA-LV Site

Kaohsiung City, 83301, Taiwan

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AURA-LV Site

Taoyuan, 333, Taiwan

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AURA-LV Site

Bangkok, 10400, Thailand

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AURA-LV Site

Chiang Mai, 50200, Thailand

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AURA-LV Site

Kharkiv, 61103, Ukraine

Location

AURA-LV Site

Kyiv, 02125, Ukraine

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AURA-LV Site

Kyiv, 04050, Ukraine

Location

AURA-LV Site

Lutsk, 43005, Ukraine

Location

AURA-LV Site

Zaporizhzhya, 69600, Ukraine

Location

Related Publications (2)

• 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.

  PMID: 22087680 BACKGROUND

• Appel GB, Contreras G, Dooley MA, Ginzler EM, Isenberg D, Jayne D, Li LS, Mysler E, Sanchez-Guerrero J, Solomons N, Wofsy D; Aspreva Lupus Management Study Group. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009 May;20(5):1103-12. doi: 10.1681/ASN.2008101028. Epub 2009 Apr 15.

  PMID: 19369404 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis

Interventions

voclosporin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rashieda Gluck
• Organization: Aurinia Pharmaceuticals

clinicaltrials@auriniapharma.com

1 (250) 744-2487

Study Officials

• Mary Anne Dooley, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 19, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2017
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Locations

UA (5); ME (5); BU (4); TH (2); BA (2); US (14); RU (15); ES (2); TW (2); CN (1); SR (4); SE (2); BE (4); PH (8); EC (2); PL (4); SG (2); KR (5); GU (1); GE (2)