Aurinia Renal Response in Active Lupus With Voclosporin

NCT03021499 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AUR-VCS-2016-01
• Study Type: interventional
• Target: 358
• Locations: 30 countries
• Sites: 181

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.

Conditions

Lupus Nephritis

Keywords

lupus nephritis; calcineurin inhibitors; voclosporin

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adjudicated Renal Response at Week 52

  The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria * UPCR of ≤0.5 mg/mg \& * eGFR ≥60 mL/min/1.73 m2 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 Weeks 44 through 52, prior to assessment Note:To be disqualified from renal response, the subject had to fail both eGFR measures (i.e., confirmed eGFR \<60 mL/min/1.73 m2 \& confirmed \>20% drop from baseline) \& have an associated treatment-related or disease-related AE that impacted eGFR Withdrawals prior to Week 52 with insufficient Week 52 data to determine response were defined non responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response

  52 Weeks

Secondary Outcomes (13)

• Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less

  52 Weeks

• Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days)

  52 Weeks

• Number of Participants With Renal Response at Week 24

  Week 24

• Number of Subjects With Partial Renal Response at Weeks 24 & 52

  Weeks 24 and 52

• Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg)

  Week 52

Study Arms (2)

Voclosporin

EXPERIMENTAL

oral, 23.7 mg twice daily (BID)

Drug: Voclosporin

Placebo Oral Capsule

PLACEBO COMPARATOR

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

Drug: Placebo Oral Capsule

Interventions

Voclosporin DRUG

calcineurin inhibitor

Also known as: ISA247

Voclosporin

Placebo Oral Capsule DRUG

matching placebo capsule

Placebo Oral Capsule

Eligibility Criteria

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

You may qualify if:

• \- 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aurinia Pharmaceuticals Inc.: lead

Study Sites (185)

AURORA Investigative Center

Huntsville, Alabama, 35805, United States

Location

AURORA Investigative Center

Phoenix, Arizona, 85032, United States

Location

AURORA Investigative Center

Phoenix, Arizona, 85037, United States

Location

AURORA Investigative Center

Beverly Hills, California, 90211, United States

Location

AURORA Investigative Center

Los Angeles, California, 90022, United States

Location

AURORA Investigative Center

Los Angeles, California, 90024, United States

Location

AURORA Investigative Center

Palo Alto, California, 94305, United States

Location

AURORA Investigative Center

Thousand Oaks, California, 91360, United States

Location

AURORA Investigative Center

Torrance, California, 90502, United States

Location

AURORA Investigative Center

Aurora, Colorado, 80045, United States

Location

AURORA Investigative Center

Denver, Colorado, 80218, United States

Location

AURORA Investigative Center

New Haven, Connecticut, 06510, United States

Location

AURORA Investigative Center

Clearwater, Florida, 33765, United States

Location

AURORA Investigative Center

DeBary, Florida, 32713, United States

Location

AURORA Investigative Center

Fort Lauderdale, Florida, 33309, United States

Location

AURORA Investigative Center

Fort Myers, Florida, 33901, United States

Location

AURORA Investigative Center

Miami, Florida, 33125, United States

Location

AURORA Investigative Center

Orlando, Florida, 32810, United States

Location

AURORA Investigative Center

Winter Park, Florida, 32789, United States

Location

AURORA Investigative Center

Atlanta, Georgia, 30318, United States

Location

AURORA Investigative Center

Columbus, Georgia, 31904, United States

Location

AURORA Investigative Center

Lawrenceville, Georgia, 30046, United States

Location

AURORA Investigative Center

Chicago, Illinois, 60637, United States

Location

AURORA Investigative Center

Louisville, Kentucky, 40202, United States

Location

AURORA Investigative Center

Baton Rouge, Louisiana, 70809, United States

Location

AURORA Investigative Center

New Orleans, Louisiana, 70121, United States

Location

AURORA Investigative Center

Boston, Massachusetts, 02118, United States

Location

AURORA Investigative Center

Detroit, Michigan, 48201-2017, United States

Location

AURORA Investigative Center

Grand Blanc, Michigan, 48439, United States

Location

AURORA Investigative Center

Rochester, Minnesota, 55905, United States

Location

AURORA Investigative Center

St Louis, Missouri, 63110, United States

Location

AURORA Investigative Center

Las Vegas, Nevada, 89128, United States

Location

AURORA Investigative Center

Newark, New Jersey, 07103, United States

Location

AURORA Investigative Center

Great Neck, New York, 11021, United States

Location

AURORA Investigative Center

New York, New York, 10016, United States

Location

AURORA Investigative Center

New York, New York, 10021-4823, United States

Location

AURORA Investigative Center

New York, New York, 11203, United States

Location

AURORA Investigative Center

Syracuse, New York, 13210, United States

Location

AURORA Investigative Center

Chapel Hill, North Carolina, 27514, United States

Location

AURORA Investigative Center

Charlotte, North Carolina, 28204, United States

Location

AURORA Investigative Center

Charlotte, North Carolina, 28210, United States

Location

AURORA Investigative Center

Greenville, North Carolina, 27834, United States

Location

AURORA Investigative Center

New Bern, North Carolina, 28562, United States

Location

AURORA Investigative Center

Cleveland, Ohio, 44109, United States

Location

AURORA Investigative Center

Columbus, Ohio, 43210, United States

Location

AURORA Investigative Center

Oklahoma City, Oklahoma, 73103, United States

Location

AURORA Investigative Center

Oklahoma City, Oklahoma, 73104, United States

Location

AURORA Investigative Center

Charleston, South Carolina, 29425, United States

Location

AURORA Investigative Center

Chattanooga, Tennessee, 37408, United States

Location

AURORA Investigative Center

Hendersonville, Tennessee, 37075, United States

Location

AURORA Investigative Center

Beaumont, Texas, 77036, United States

Location

AURORA Investigative Center

Dallas, Texas, 75231, United States

Location

AURORA Investigative Center

Dallas, Texas, 75246, United States

Location

AURORA Investigative Center

Dallas, Texas, 75390, United States

Location

AURORA Investigative Center

El Paso, Texas, 79905, United States

Location

AURORA Investigative Center

El Paso, Texas, 79935, United States

Location

AURORA Investigative Center

Houston, Texas, 77030, United States

Location

AURORA Investigative Center

Arlington, Virginia, 22205, United States

Location

AURORA

Richmond, Virginia, 23298, United States

Location

AURORA Investigative Center

Buenos Aires, Argentina

Location

AURORA Investigative Center

Caba, Argentina

Location

AURORA Investigative Center

Córdoba, Argentina

Location

AURORA Investigative Center

La Plata, Argentina

Location

AURORA Investigative Center

San Miguel de Tucumán, Argentina

Location

AURORA Investigative Cener

Minsk, 220116, Belarus

Location

AURORA Investigative Center

Minsk, 223040, Belarus

Location

AURORA Investigative Center

Vitebsk, Belarus

Location

AURORA Investigative Center

Curitiba, Brazil

Location

AURORA Investigative Center

Porto Alegre, Brazil

Location

AURORA Investigative Center

Salvador, Brazil

Location

AURORA Investigative Center

São Paulo, Brazil

Location

AURORA Investigative Center

Plovdiv, Bulgaria

Location

AURORA Investigative Center

Smolyan, Bulgaria

Location

AURORA Investigative Center

Sofia, Bulgaria

Location

AURORA Investigative Center

Stara Zagora, 6001, Bulgaria

Location

AURORA Investigative Center

Vidin, Bulgaria

Location

AURORA Investigative Center

Edmonton, Alberta, Canada

Location

AURORA Investigative Center

Montreal, Quebec, Canada

Location

AURORA Investigative Center

Toronto, Canada

Location

AURORA Investigative Center

Santiago, Chile

Location

AURORA Investigative Center

Temuco, Chile

Location

AURORA Investigative Center

Valdivia, Chile

Location

AURORA Investigative Center

Barranquilla, Colombia

Location

AURORA Investigative Center

Bogotá, Colombia

Location

AURORA Investigative Center

Bucaramanga, Colombia

Location

AURORA Investigative Center

Zipaquirá, Colombia

Location

AURORA Investigative Center

San José, 10108, Costa Rica

Location

AURORA Investigative Center

San José, Costa Rica

Location

AURORA Investigative Center

Osijek, Croatia

Location

AURORA Investigative Center

Zagreb, Croatia

Location

AURORA Investigative Center

Santiago de los Caballeros, Dominican Republic

Location

AURORA Investigative Center

Santo Domingo, Dominican Republic

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AURORA Investigative Center

Guatemala City, Guatemala

Location

AURORA Investigative Center

Kita, Osaka, Japan

Location

AURORA Investigative Center

Chiba, Japan

Location

AURORA Investigative Center

Hiroshima, Japan

Location

AURORA Investigative Center

Ishikawa, Japan

Location

AURORA Investigative Center

Kita-ku, Japan

Location

AURORA Investigative Center

Kitakyushu, Japan

Location

AURORA Investigative Center

Maebashi, Japan

Location

AURORA Investigative Center

Nagasaki, Japan

Location

AURORA Investigative Center

Niigata, Japan

Location

AURORA Investigative Center

Sapporo, Japan

Location

AURORA Investigative Center

Sendai, Japan

Location

AURORA Investigative Center

Tokyo, Japan

Location

AURORA Investigative Center

Kuala Lumpur, 50586, Malaysia

Location

AURORA Investigative Center

Baja California, Mexico

Location

AURORA Investigative Center

Coahuila, Mexico

Location

AURORA Investigative Center

Guadalajara, Mexico

Location

AURORA Investigative Center

León, Mexico

Location

AURORA Investigative Center

Mexico City, Mexico

Location

AURORA Investigative Center

Mérida, Mexico

Location

AURORA Investigative Center

Monclova, Mexico

Location

AURORA Investigative Center

Oaxaca City, Mexico

Location

AURORA Investigative Center

San Luis Potosí City, Mexico

Location

AURORA Investigative Center

Sinaloa, Mexico

Location

AURORA Investigative Center

Amsterdam, Netherlands

Location

AURORA Investigative Center

Groningen, Netherlands

Location

AURORA Investigative Center

Leiden, Netherlands

Location

AURORA Investigative Center

Maastricht, Netherlands

Location

AURORA Investigative Center

Rotterdam, Netherlands

Location

AURORA Investigative Center

Skopje, 1000, North Macedonia

Location

AURORA Investigative Center

Lima, Peru

Location

AURORA Investigative Center

Trujillo, Peru

Location

AURORA Investigative Center

Angeles City, Philippines

Location

AURORA Investigative Center

Davao City, Philippines

Location

AURORA Investigative Center

Lipa, Philippines

Location

AURORA Investigative Center

Manila, Philippines

Location

AURORA Investigative Center

Quezon City, Philippines

Location

AURORA Investigative Center

Katowice, Poland

Location

AURORA Investigative Center

Warsaw, Poland

Location

AURORA Investigative Center

Wroclaw, Poland

Location

AURORA Investigative Center

San Juan, Puerto Rico

Location

AURORA Investigative Center

Kazan', Russia

Location

AURORA Investigative Center

Kemerovo, Russia

Location

AURORA Investigative Center

Krasnoyarsk, Russia

Location

AURORA Investigative Center

Moscow, Russia

Location

AURORA Investigative Center

Omsk, Russia

Location

AURORA Investigative Center

Petrozavodsk, Russia

Location

AURORA Investigative Center

Rostov-on-Don, Russia

Location

AURORA Investigative Center

Saint Petersburg, 197110, Russia

Location

AURORA Investigative Center

Saint Petersburg, Russia

Location

AURORA Investigative Center

Samara, Russia

Location

AURORA Investigative Center

Saratov, Russia

Location

AURORA Investigative Center

Tolyatti, 445009, Russia

Location

AURORA Investigative Center

Yaroslavl, 150062, Russia

Location

AURORA Investigative Center

Yekaterinburg, Russia

Location

AURORA Investigative Center

Belgrade, Serbia

Location

AURORA Investigative Center

Niš, Serbia

Location

AURORA Investigative Center

Cape Town, South Africa

Location

AURORA Investigative Center

Johannesburg, South Africa

Location

AURORA Investigative Center

Pretoria, South Africa

Location

AURORA Investigative Center

Stellenbosch, South Africa

Location

AURORA Investigative Center

Daejeon, South Korea

Location

AURORA Investigative Center

Seoul, South Korea

Location

AURORA Investigative Center

Suwon, South Korea

Location

AURORA Investigative Center

Wŏnju, South Korea

Location

AURORA Investigative Center

A Coruña, Spain

Location

AURORA Investigative Center

Barcelona, 08025, Spain

Location

AURORA Investigative Center

Madrid, 28006, Spain

Location

AURORA Investigative Center

Madrid, 28041, Spain

Location

AURORA Investigative Center

Valencia, Spain

Location

AURORA Investigative Center

Chang-hua, Taiwan

Location

AURORA Investigative Center

Taichung, Taiwan

Location

AURORA Investigative Center

Taoyuan District, Taiwan

Location

AURORA Investigative Center

Bangkok, Thailand

Location

AURORA Investigative Center

Chiang Mai, Thailand

Location

AURORA Investigative Center

Songkhla, Thailand

Location

AURORA Investigative Center

Balcalı, Turkey (Türkiye)

Location

AURORA Investigative Center

Bursa, Turkey (Türkiye)

Location

AURORA Investigative Center

Efeler, Turkey (Türkiye)

Location

AURORA Investigative Center

Fatih, Turkey (Türkiye)

Location

AURORA Investigative Center

Istanbul, Turkey (Türkiye)

Location

AURORA Investigative Center

Konyaalti, Turkey (Türkiye)

Location

AURORA Investigative Center

Malatya, Turkey (Türkiye)

Location

AURORA Investigative Center

Yenimahalle, Turkey (Türkiye)

Location

AURORA Investigative Center

Kharkiv, 61103, Ukraine

Location

AURORA Investigative Center

Kyiv, 02125, Ukraine

Location

AURORA Investigative Center

Kyiv, Ukraine

Location

AURORA Investigative Center

Lutsk, Ukraine

Location

AURORA Investigative Center

Odesa, 65025, Ukraine

Location

AURORA Investigative Center

Vinnytsia, 21018, Ukraine

Location

AURORA Investigative Center

Zaporizhzhya, Ukraine

Location

AURORA Investigative Center

Hanoi, Vietnam

Location

AURORA Investigative Center

Ho Chi Minh City, Vietnam

Location

Related Publications (9)

• 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.

  PMID: 22879439 BACKGROUND

• 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.

  PMID: 24330024 BACKGROUND

• 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.

  PMID: 23996158 BACKGROUND

• 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.

  PMID: 23736966 BACKGROUND

• 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 RESULT

• 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.

  PMID: 21943027 RESULT

• Palmer BF, Tumlin JA, Radhakrishnan J, Rehaume LM, Cross JL, Huizinga RB. The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin. Front Nephrol. 2025 Mar 17;5:1540471. doi: 10.3389/fneph.2025.1540471. eCollection 2025.

  PMID: 40166657 DERIVED

• Menn-Josephy H, Hodge LS, Birardi V, Leher H. Efficacy of Voclosporin in Proliferative Lupus Nephritis with High Levels of Proteinuria. Clin J Am Soc Nephrol. 2024 Mar 1;19(3):309-318. doi: 10.2215/CJN.0000000000000297. Epub 2023 Dec 18.

  PMID: 38110196 DERIVED

• Rovin BH, Teng YKO, Ginzler EM, Arriens C, Caster DJ, Romero-Diaz J, Gibson K, Kaplan J, Lisk L, Navarra S, Parikh SV, Randhawa S, Solomons N, Huizinga RB. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021 May 29;397(10289):2070-2080. doi: 10.1016/S0140-6736(21)00578-X. Epub 2021 May 7.

  PMID: 33971155 DERIVED

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

• Samir Parikh, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: January 12, 2017
• First Posted: January 16, 2017
• Study Start: May 17, 2017
• Primary Completion: September 24, 2019
• Study Completion: October 10, 2019
• Last Updated: March 27, 2023
• Results First Posted: June 16, 2021

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); CO (2); JP (12); PR (1); BE (3); GU (1); NO (1); PH (5); BU (5); TH (3); US (59); PL (3); AR (5); ZA (4); VN (2); ME (10); PE (2); CA (3); NL (5); RU (14); CL (3); SE (2); KR (4); UA (7); CR (2); MY (1); BR (4); DO (2); TW (3); TU (8)