Aurinia Renal Response in Active Lupus With Voclosporin (AURORA)

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

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.

Study Overview

• Status: Completed
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Voclosporin; Drug: Placebo Oral Capsule

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 mycophenolate mofetil (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
• Enrollment (Actual): 358
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • AURORA Investigative Center
  • Caba, Argentina
    • AURORA Investigative Center
  • Córdoba, Argentina
    • AURORA Investigative Center
  • La Plata, Argentina
    • AURORA Investigative Center
  • San Miguel De Tucumán, Argentina
    • AURORA Investigative Center
• Belarus
  • Minsk, Belarus, 220116
    • AURORA Investigative Cener
  • Minsk, Belarus, 223040
    • AURORA Investigative Center
  • Vitebsk, Belarus
    • AURORA Investigative Center
• Brazil
  • Curitiba, Brazil
    • AURORA Investigative Center
  • Porto Alegre, Brazil
    • AURORA Investigative Center
  • Salvador, Brazil
    • AURORA Investigative Center
  • São Paulo, Brazil
    • AURORA Investigative Center
• Bulgaria
  • Plovdiv, Bulgaria
    • AURORA Investigative Center
  • Smolyan, Bulgaria
    • AURORA Investigative Center
  • Sofia, Bulgaria
    • AURORA Investigative Center
  • Stara Zagora, Bulgaria, 6001
    • AURORA Investigative Center
  • Vidin, Bulgaria
    • AURORA Investigative Center
• Canada
  • Toronto, Canada
    • AURORA Investigative Center
  • Alberta
    • Edmonton, Alberta, Canada
      • AURORA Investigative Center
  • Quebec
    • Montreal, Quebec, Canada
      • AURORA Investigative Center
    • Montréal, Quebec, Canada
      • AURORA Investigative Center
• Chile
  • Santiago, Chile
    • AURORA Investigative Center
  • Temuco, Chile
    • AURORA Investigative Center
  • Valdivia, Chile
    • AURORA Investigative Center
• Colombia
  • Barranquilla, Colombia
    • AURORA Investigative Center
  • Bogotá, Colombia
    • AURORA Investigative Center
  • Bucaramanga, Colombia
    • AURORA Investigative Center
  • Zipaquirá, Colombia
    • AURORA Investigative Center
• Costa Rica
  • San José, Costa Rica, 10108
    • AURORA Investigative Center
  • San José, Costa Rica
    • AURORA Investigative Center
• Croatia
  • Osijek, Croatia
    • AURORA Investigative Center
  • Zagreb, Croatia
    • AURORA Investigative Center
• Dominican Republic
  • Santiago de los Caballeros, Dominican Republic
    • AURORA Investigative Center
  • Santo Domingo, Dominican Republic
    • AURORA Investigative Center
• Guatemala
  • Guatemala City, Guatemala
    • AURORA Investigative Center
• Japan
  • Chiba, Japan
    • AURORA Investigative Center
  • Hiroshima, Japan
    • AURORA Investigative Center
  • Ishikawa, Japan
    • AURORA Investigative Center
  • Kita, Japan
    • AURORA Investigative Center
  • Kitakyushu, Japan
    • AURORA Investigative Center
  • Maebashi, Japan
    • AURORA Investigative Center
  • Nagasaki, Japan
    • AURORA Investigative Center
  • Niigata, Japan
    • AURORA Investigative Center
  • Sapporo, Japan
    • AURORA Investigative Center
  • Sendai, Japan
    • AURORA Investigative Center
  • Tokyo, Japan
    • AURORA Investigative Center
  • Osaka
    • Kita, Osaka, Japan
      • AURORA Investigative Center
• Korea, Republic of
  • Daejeon, Korea, Republic of
    • AURORA Investigative Center
  • Seoul, Korea, Republic of
    • AURORA Investigative Center
  • Suwon-si, Korea, Republic of
    • AURORA Investigative Center
  • Wŏnju, Korea, Republic of
    • AURORA Investigative Center
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • AURORA Investigative Center
• Mexico
  • Baja California, Mexico
    • AURORA Investigative Center
  • Coahuila, Mexico
    • AURORA Investigative Center
  • Guadalajara, Mexico
    • AURORA Investigative Center
  • León, Mexico
    • AURORA Investigative Center
  • Mexico City, Mexico
    • AURORA Investigative Center
  • Monclova, Mexico
    • AURORA Investigative Center
  • Mérida, Mexico
    • AURORA Investigative Center
  • Oaxaca, Mexico
    • AURORA Investigative Center
  • San Luis Potosí, Mexico
    • AURORA Investigative Center
  • Sinaloa, Mexico
    • AURORA Investigative Center
• Netherlands
  • Amsterdam, Netherlands
    • AURORA Investigative Center
  • Groningen, Netherlands
    • AURORA Investigative Center
  • Leiden, Netherlands
    • AURORA Investigative Center
  • Maastricht, Netherlands
    • AURORA Investigative Center
  • Rotterdam, Netherlands
    • AURORA Investigative Center
• North Macedonia
  • Skopje, North Macedonia, 1000
    • AURORA Investigative Center
• Peru
  • Lima, Peru
    • AURORA Investigative Center
  • Trujillo, Peru
    • AURORA Investigative Center
• Philippines
  • Angeles City, Philippines
    • AURORA Investigative Center
  • Davao City, Philippines
    • AURORA Investigative Center
  • Lipa, Philippines
    • AURORA Investigative Center
  • Manila, Philippines
    • AURORA Investigative Center
  • Quezon City, Philippines
    • AURORA Investigative Center
• Poland
  • Katowice, Poland
    • AURORA Investigative Center
  • Warszawa, Poland
    • AURORA Investigative Center
  • Wrocław, Poland
    • AURORA Investigative Center
• Puerto Rico
  • San Juan, Puerto Rico
    • AURORA Investigative Center
• Russian Federation
  • Kazan, Russian Federation
    • AURORA Investigative Center
  • Kemerovo, Russian Federation
    • AURORA Investigative Center
  • Krasnoyarsk, Russian Federation
    • AURORA Investigative Center
  • Moscow, Russian Federation
    • AURORA Investigative Center
  • Omsk, Russian Federation
    • AURORA Investigative Center
  • Petrozavodsk, Russian Federation
    • AURORA Investigative Center
  • Rostov-on-Don, Russian Federation
    • AURORA Investigative Center
  • Saint Petersburg, Russian Federation, 197110
    • AURORA Investigative Center
  • Saint Petersburg, Russian Federation
    • AURORA Investigative Center
  • Samara, Russian Federation
    • AURORA Investigative Center
  • Saratov, Russian Federation
    • AURORA Investigative Center
  • Tol'yatti, Russian Federation, 445009
    • AURORA Investigative Center
  • Yaroslavl, Russian Federation, 150062
    • AURORA Investigative Center
  • Yekaterinburg, Russian Federation
    • AURORA Investigative Center
• Serbia
  • Belgrade, Serbia
    • AURORA Investigative Center
  • Niš, Serbia
    • AURORA Investigative Center
• South Africa
  • Cape town, South Africa
    • AURORA Investigative Center
  • Johannesburg, South Africa
    • AURORA Investigative Center
  • Pretoria, South Africa
    • AURORA Investigative Center
  • Stellenbosch, South Africa
    • AURORA Investigative Center
• Spain
  • A Coruña, Spain
    • AURORA Investigative Center
  • Barcelona, Spain, 08025
    • AURORA Investigative Center
  • Madrid, Spain, 28006
    • AURORA Investigative Center
  • Madrid, Spain, 28041
    • AURORA Investigative Center
  • Valencia, Spain
    • AURORA Investigative Center
• Taiwan
  • Chang Hua, Taiwan
    • AURORA Investigative Center
  • Chang-hua, Taiwan
    • AURORA Investigative Center
  • Taichung, Taiwan
    • AURORA Investigative Center
  • Taoyuan, Taiwan
    • AURORA Investigative Center
• Thailand
  • Bangkok, Thailand
    • AURORA Investigative Center
  • Chiang Mai, Thailand
    • AURORA Investigative Center
  • Songkhla, Thailand
    • AURORA Investigative Center
• Turkey
  • Balcalı, Turkey
    • AURORA Investigative Center
  • Bursa, Turkey
    • AURORA Investigative Center
  • Efeler, Turkey
    • AURORA Investigative Center
  • Fatih, Turkey
    • AURORA Investigative Center
  • Konyaalti, Turkey
    • AURORA Investigative Center
  • Malatya, Turkey
    • AURORA Investigative Center
  • Yenimahalle, Turkey
    • AURORA Investigative Center
  • İstanbul, Turkey
    • AURORA Investigative Center
• Ukraine
  • Kharkiv, Ukraine, 61103
    • AURORA Investigative Center
  • Kyiv, Ukraine, 02125
    • AURORA Investigative Center
  • Kyiv, Ukraine
    • AURORA Investigative Center
  • Luts'k, Ukraine
    • AURORA Investigative Center
  • Odessa, Ukraine, 65025
    • AURORA Investigative Center
  • Vinnytsya, Ukraine, 21018
    • AURORA Investigative Center
  • Zaporizhzhya, Ukraine
    • AURORA Investigative Center
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • AURORA Investigative Center
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • AURORA Investigative Center
    • Phoenix, Arizona, United States, 85037
      • AURORA Investigative Center
  • California
    • Beverly Hills, California, United States, 90211
      • AURORA Investigative Center
    • Los Angeles, California, United States, 90022
      • AURORA Investigative Center
    • Los Angeles, California, United States, 90024
      • AURORA Investigative Center
    • Palo Alto, California, United States, 94305
      • AURORA Investigative Center
    • Thousand Oaks, California, United States, 91360
      • AURORA Investigative Center
    • Torrance, California, United States, 90502
      • AURORA Investigative Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • AURORA Investigative Center
    • Denver, Colorado, United States, 80218
      • AURORA Investigative Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • AURORA Investigative Center
  • Florida
    • Clearwater, Florida, United States, 33765
      • AURORA Investigative Center
    • DeBary, Florida, United States, 32713
      • AURORA Investigative Center
    • Fort Lauderdale, Florida, United States, 33309
      • AURORA Investigative Center
    • Fort Myers, Florida, United States, 33901
      • AURORA Investigative Center
    • Miami, Florida, United States, 33125
      • AURORA Investigative Center
    • Orlando, Florida, United States, 32810
      • AURORA Investigative Center
    • Winter Park, Florida, United States, 32789
      • AURORA Investigative Center
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • AURORA Investigative Center
    • Columbus, Georgia, United States, 31904
      • AURORA Investigative Center
    • Lawrenceville, Georgia, United States, 30046
      • AURORA Investigative Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • AURORA Investigative Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • AURORA Investigative Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • AURORA Investigative Center
    • New Orleans, Louisiana, United States, 70121
      • AURORA Investigative Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • AURORA Investigative Center
  • Michigan
    • Detroit, Michigan, United States, 48201-2017
      • AURORA Investigative Center
    • Grand Blanc, Michigan, United States, 48439
      • AURORA Investigative Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • AURORA Investigative Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • AURORA Investigative Center
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • AURORA Investigative Center
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • AURORA Investigative Center
  • New York
    • Great Neck, New York, United States, 11021
      • AURORA Investigative Center
    • New York, New York, United States, 10016
      • AURORA Investigative Center
    • New York, New York, United States, 10021-4823
      • AURORA Investigative Center
    • New York, New York, United States, 11203
      • AURORA Investigative Center
    • Syracuse, New York, United States, 13210
      • AURORA Investigative Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • AURORA Investigative Center
    • Charlotte, North Carolina, United States, 28204
      • AURORA Investigative Center
    • Charlotte, North Carolina, United States, 28210
      • AURORA Investigative Center
    • Greenville, North Carolina, United States, 27834
      • AURORA Investigative Center
    • New Bern, North Carolina, United States, 28562
      • AURORA Investigative Center
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • AURORA Investigative Center
    • Columbus, Ohio, United States, 43210
      • AURORA Investigative Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • AURORA Investigative Center
    • Oklahoma City, Oklahoma, United States, 73104
      • AURORA Investigative Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • AURORA Investigative Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37408
      • AURORA Investigative Center
    • Hendersonville, Tennessee, United States, 37075
      • AURORA Investigative Center
  • Texas
    • Beaumont, Texas, United States, 77036
      • AURORA Investigative Center
    • Dallas, Texas, United States, 75231
      • AURORA Investigative Center
    • Dallas, Texas, United States, 75246
      • AURORA Investigative Center
    • Dallas, Texas, United States, 75390
      • AURORA Investigative Center
    • El Paso, Texas, United States, 79905
      • AURORA Investigative Center
    • El Paso, Texas, United States, 79935
      • AURORA Investigative Center
    • Houston, Texas, United States, 77030
      • AURORA Investigative Center
  • Virginia
    • Arlington, Virginia, United States, 22205
      • AURORA Investigative Center
    • Richmond, Virginia, United States, 23298
      • Aurora
• Vietnam
  • Hanoi, Vietnam
    • AURORA Investigative Center
  • Ho Chi Minh City, Vietnam
    • AURORA Investigative Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Voclosporin; oral, 23.7 mg twice daily (BID)	Drug: Voclosporin; calcineurin inhibitor; Other Names: ISA247
Placebo Comparator: Placebo Oral Capsule; Voclosporin placebo, oral, 3 capsules twice daily (BID)	Drug: Placebo Oral Capsule; matching placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less	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)	Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less.	52 Weeks
Number of Participants With Renal Response at Week 24	Number of subjects showing renal response at Week 24. Renal response was adjudicated based on blinded data by an Independent Clinical Endpoints Committee based on 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%, and 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 16 through 24, just prior to the renal response 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 AND confirmed >20% drop from BL) & have an associated treatment-related or disease-related AE that impacted eGFR. Subjects who withdrew prior to the Week 24 assessment and provided insufficient Week 24 data to determine response were defined as non-responders. Subjects who discontinued study drug but continued to attend study visits had their data assessed for response.	Week 24
Number of Subjects With Partial Renal Response at Weeks 24 & 52	Number of subjects with partial Renal Response (defined as a 50% reduction in UPCR from baseline) at Week 24 and at Week 52. Baseline UPCR is the average of 2 pre-randomisation values.	Weeks 24 and 52
Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg)	Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg)	Week 52
Duration of Renal Response (Number of Days)	Duration in days until second occurrence of UPCR >0.5 mg/mg in those subjects who achieve a reduction in UPCR to below 0.5 mg/mg	Week 52
Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio	Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio	52 Weeks
Time to 50% Reduction in UPCR (Number of Days)	Time in days to reduction in Urine Protein Creatinine Ratio to decrease by 50% compared to baseline. Baseline is the average of two pre-randomisation values.	52 weeks
Change From Baseline in eGFR	Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2	Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Change From Baseline in UPCR	Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.	Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.
Number of Subjects With Renal Response With Low Dose Steroids	Programmed Renal Response whilst on low dose steroids (<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52	Week 24 and Week 52
Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)	Change from baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24 and 52. The SELENA-SLEDAI tool is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-SLEDAI total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.	Week 24 and Week 52
Change From Baseline in Patient Reported Outcomes	Health-related quality of life (HRQoL) information was collected using the Short Form Health Survey (SF-36) HRQoL assessment and the LupusPRO (v1.7) assessment. The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. Scoring ranges from 0 to 100 with higher scores reflecting better health. LupusPro assessment is a patient-reported questionnaire regarding the effect of lupus or its treatment on the patient's health, quality of life, and the medical care received related to lupus. The questionnaire consists of 43 questions within 8 HRQOL domains and 4 Non-HRQoL domains. Scores range from 0 to 100 with higher scores reflecting better quality of life.	Week 24 and Week 52

Collaborators and Investigators

• Sponsor: Aurinia Pharmaceuticals Inc.
• Investigators: Principal Investigator: Samir Parikh, MD, Ohio State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Lancet. 2021 May 29;397(10289):2048.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: lupus nephritis; voclosporin; calcineurin inhibitors
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: AUR-VCS-2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No