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Aurinia Renal Response in Active Lupus With Voclosporin

NCT ID: NCT03021499

Last Updated: 2023-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2019-10-10

Brief Summary

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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.

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A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

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Detailed Description

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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.

Conditions

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Lupus Nephritis

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

oral, 23.7 mg twice daily (BID)

Group Type EXPERIMENTAL

Voclosporin

Intervention Type DRUG

calcineurin inhibitor

Placebo Oral Capsule

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type DRUG

matching placebo capsule

Interventions

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Voclosporin

calcineurin inhibitor

Intervention Type DRUG

Placebo Oral Capsule

matching placebo capsule

Intervention Type DRUG

Other Intervention Names

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ISA247

Eligibility Criteria

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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.
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

Principal Investigators

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Samir Parikh, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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AURORA Investigative Center

Huntsville, Alabama, United States

Site Status

AURORA Investigative Center

Phoenix, Arizona, United States

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AURORA Investigative Center

Phoenix, Arizona, United States

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AURORA Investigative Center

Beverly Hills, California, United States

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AURORA Investigative Center

Los Angeles, California, United States

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AURORA Investigative Center

Los Angeles, California, United States

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AURORA Investigative Center

Palo Alto, California, United States

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AURORA Investigative Center

Thousand Oaks, California, United States

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AURORA Investigative Center

Torrance, California, United States

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AURORA Investigative Center

Aurora, Colorado, United States

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AURORA Investigative Center

Denver, Colorado, United States

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AURORA Investigative Center

New Haven, Connecticut, United States

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AURORA Investigative Center

Clearwater, Florida, United States

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AURORA Investigative Center

DeBary, Florida, United States

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AURORA Investigative Center

Fort Lauderdale, Florida, United States

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AURORA Investigative Center

Fort Myers, Florida, United States

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AURORA Investigative Center

Miami, Florida, United States

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AURORA Investigative Center

Orlando, Florida, United States

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AURORA Investigative Center

Winter Park, Florida, United States

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AURORA Investigative Center

Atlanta, Georgia, United States

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AURORA Investigative Center

Columbus, Georgia, United States

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AURORA Investigative Center

Lawrenceville, Georgia, United States

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AURORA Investigative Center

Chicago, Illinois, United States

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AURORA Investigative Center

Louisville, Kentucky, United States

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AURORA Investigative Center

Baton Rouge, Louisiana, United States

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AURORA Investigative Center

New Orleans, Louisiana, United States

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AURORA Investigative Center

Boston, Massachusetts, United States

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AURORA Investigative Center

Detroit, Michigan, United States

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AURORA Investigative Center

Grand Blanc, Michigan, United States

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AURORA Investigative Center

Rochester, Minnesota, United States

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AURORA Investigative Center

St Louis, Missouri, United States

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AURORA Investigative Center

Las Vegas, Nevada, United States

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AURORA Investigative Center

Newark, New Jersey, United States

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AURORA Investigative Center

Great Neck, New York, United States

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New York, New York, United States

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AURORA Investigative Center

New York, New York, United States

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AURORA Investigative Center

New York, New York, United States

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AURORA Investigative Center

Syracuse, New York, United States

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AURORA Investigative Center

Chapel Hill, North Carolina, United States

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AURORA Investigative Center

Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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New Bern, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Charleston, South Carolina, United States

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Chattanooga, Tennessee, United States

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Hendersonville, Tennessee, United States

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AURORA Investigative Center

Beaumont, Texas, United States

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AURORA Investigative Center

Dallas, Texas, United States

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Dallas, Texas, United States

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AURORA Investigative Center

Dallas, Texas, United States

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AURORA Investigative Center

El Paso, Texas, United States

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AURORA Investigative Center

El Paso, Texas, United States

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AURORA Investigative Center

Houston, Texas, United States

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AURORA Investigative Center

Arlington, Virginia, United States

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AURORA

Richmond, Virginia, United States

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AURORA Investigative Center

Buenos Aires, , Argentina

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Caba, , Argentina

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Córdoba, , Argentina

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La Plata, , Argentina

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San Miguel de Tucumán, , Argentina

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AURORA Investigative Cener

Minsk, , Belarus

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Minsk, , Belarus

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Vitebsk, , Belarus

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Curitiba, , Brazil

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Porto Alegre, , Brazil

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Salvador, , Brazil

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São Paulo, , Brazil

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Plovdiv, , Bulgaria

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Smolyan, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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AURORA Investigative Center

Vidin, , Bulgaria

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Edmonton, Alberta, Canada

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Montreal, Quebec, Canada

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Toronto, , Canada

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AURORA Investigative Center

Santiago, , Chile

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Temuco, , Chile

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Valdivia, , Chile

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Zipaquirá, , Colombia

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San José, , Costa Rica

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San José, , Costa Rica

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Osijek, , Croatia

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Zagreb, , Croatia

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Santiago de los Caballeros, , Dominican Republic

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Santo Domingo, , Dominican Republic

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Guatemala City, , Guatemala

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Kita, Osaka, Japan

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Chiba, , Japan

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Hiroshima, , Japan

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Ishikawa, , Japan

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Kita-ku, , Japan

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Kitakyushu, , Japan

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Maebashi, , Japan

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Nagasaki, , Japan

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Niigata, , Japan

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Sapporo, , Japan

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Sendai, , Japan

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Tokyo, , Japan

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Kuala Lumpur, , Malaysia

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Baja California, , Mexico

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Coahuila, , Mexico

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Guadalajara, , Mexico

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León, , Mexico

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Mexico City, , Mexico

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Mérida, , Mexico

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Monclova, , Mexico

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Oaxaca City, , Mexico

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San Luis Potosí City, , Mexico

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Sinaloa, , Mexico

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Amsterdam, , Netherlands

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Groningen, , Netherlands

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Leiden, , Netherlands

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Maastricht, , Netherlands

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Rotterdam, , Netherlands

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Skopje, , North Macedonia

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Lima, , Peru

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Trujillo, , Peru

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Angeles City, , Philippines

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Davao City, , Philippines

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Lipa, , Philippines

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Manila, , Philippines

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Quezon City, , Philippines

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Katowice, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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San Juan, , Puerto Rico

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AURORA Investigative Center

Kazan', , Russia

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Kemerovo, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Omsk, , Russia

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Petrozavodsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Tolyatti, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Belgrade, , Serbia

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Niš, , Serbia

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Cape Town, , South Africa

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Johannesburg, , South Africa

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Pretoria, , South Africa

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Stellenbosch, , South Africa

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Daejeon, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Wŏnju, , South Korea

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AURORA Investigative Center

A Coruña, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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AURORA Investigative Center

Valencia, , Spain

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AURORA Investigative Center

Chang-hua, , Taiwan

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AURORA Investigative Center

Taichung, , Taiwan

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Taoyuan District, , Taiwan

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AURORA Investigative Center

Bangkok, , Thailand

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Chiang Mai, , Thailand

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Songkhla, , Thailand

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Balcalı, , Turkey (Türkiye)

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AURORA Investigative Center

Bursa, , Turkey (Türkiye)

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AURORA Investigative Center

Efeler, , Turkey (Türkiye)

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AURORA Investigative Center

Fatih, , Turkey (Türkiye)

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AURORA Investigative Center

Istanbul, , Turkey (Türkiye)

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Konyaalti, , Turkey (Türkiye)

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AURORA Investigative Center

Malatya, , Turkey (Türkiye)

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AURORA Investigative Center

Yenimahalle, , Turkey (Türkiye)

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AURORA Investigative Center

Kharkiv, , Ukraine

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AURORA Investigative Center

Kyiv, , Ukraine

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AURORA Investigative Center

Kyiv, , Ukraine

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AURORA Investigative Center

Lutsk, , Ukraine

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AURORA Investigative Center

Odesa, , Ukraine

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AURORA Investigative Center

Vinnytsia, , Ukraine

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AURORA Investigative Center

Zaporizhzhya, , Ukraine

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AURORA Investigative Center

Hanoi, , Vietnam

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AURORA Investigative Center

Ho Chi Minh City, , Vietnam

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Countries

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United States Argentina Belarus Brazil Bulgaria Canada Chile Colombia Costa Rica Croatia Dominican Republic Guatemala Japan Malaysia Mexico Netherlands North Macedonia Peru Philippines Poland Puerto Rico Russia Serbia South Africa South Korea Spain Taiwan Thailand Turkey (Türkiye) Ukraine Vietnam

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)

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)

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 RESULT
PMID: 22087680 (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 RESULT
PMID: 21943027 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40166657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38110196 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33971155 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol: Protocol V1.0 01Dec2016

View Document

Document Type: Study Protocol: Protocol V2.0 04May2017

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AUR-VCS-2016-01

Identifier Type: -

Identifier Source: org_study_id

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