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Aurinia Renal Response in Active Lupus With Voclosporin (AURORA)

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ClinicalTrials.gov Identifier: NCT03021499
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Voclosporin Drug: Placebo Oral Capsule Phase 3

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 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  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 17, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Voclosporin
oral, 23.7 mg BID
Drug: Voclosporin
calcineurin inhibitor
Other Name: ISA247

Placebo Comparator: Placebo Oral Capsule
Voclosporin placebo, oral, 3 capsules BID
Drug: Placebo Oral Capsule
matching placebo capsule




Primary Outcome Measures :
  1. The number of subjects achieving renal response [ Time Frame: 52 Weeks ]
    The number of subjects achieving renal response


Secondary Outcome Measures :
  1. Time to UPCR of ≤0.5 mg/mg. [ Time Frame: 52 Weeks ]
    Time to UPCR of ≤0.5 mg/mg.

  2. Partial renal response [ Time Frame: Weeks 24 and 52 ]
    Partial renal response

  3. Time to 50% reduction in UPCR from baseline. [ Time Frame: 52 Weeks ]
    Time to 50% reduction in UPCR from baseline.

  4. Renal response at Week 52 [ Time Frame: 52 Weeks ]
    Renal response at Week 52

  5. Duration of renal response [ Time Frame: 52 Weeks ]
    Duration of renal response

  6. Change from baseline in laboratory parameters at each time point [ Time Frame: 52 Weeks ]
    Change from baseline in laboratory parameters at each time point

  7. Renal response with low-dose steroids [ Time Frame: 52 Weeks ]
    Renal response with low-dose steroids

  8. Quality of Life questionnaires [ Time Frame: Weeks 12, 24 and 52 ]
    Quality of Life questionnaires

  9. Change from baseline in the SELENA-SLEDAI Index score [ Time Frame: Weeks 24 and 52 ]
    Change from baseline in the SELENA-SLEDAI Index score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021499


Contacts
Contact: Robert Huizinga 250 708 4322 rhuizinga@auriniapharma.com
Contact: Rashieda Gluck rgluck@auriniapharma.com

  Hide Study Locations
Locations
United States, Alabama
AURORA Investigative Center Recruiting
Huntsville, Alabama, United States, 35805
United States, Arizona
AURORA Investigative Center Recruiting
Phoenix, Arizona, United States, 85032
AURORA Investigative Center Recruiting
Phoenix, Arizona, United States, 85037
United States, California
AURORA Investigative Center Recruiting
Beverly Hills, California, United States, 90211
AURORA Investigative Center Recruiting
Los Angeles, California, United States, 90022
AURORA Investigative Center Recruiting
Los Angeles, California, United States, 90024
AURORA Investigative Center Recruiting
Palo Alto, California, United States, 94305
AURORA Investigative Center Recruiting
Thousand Oaks, California, United States, 91360
AURORA Investigative Center Recruiting
Torrance, California, United States, 90502
United States, Colorado
AURORA Investigative Center Recruiting
Aurora, Colorado, United States, 80045
AURORA Investigative Center Recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
AURORA Investigative Center Recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
AURORA Investigative Center Recruiting
Clearwater, Florida, United States, 33765
AURORA Investigative Center Recruiting
DeBary, Florida, United States, 32713
AURORA Investigative Center Recruiting
Fort Lauderdale, Florida, United States, 33309
AURORA Investigative Center Recruiting
Fort Myers, Florida, United States, 33901
AURORA Investigative Center Withdrawn
Hialeah, Florida, United States, 33016
AURORA Investigative Center Recruiting
Miami, Florida, United States, 33125
AURORA Investigative Center Withdrawn
Miami, Florida, United States, 33126
AURORA Investigative Center Recruiting
Orlando, Florida, United States, 32810
AURORA Investigative Center Recruiting
Winter Park, Florida, United States, 32789
United States, Georgia
AURORA Investigative Center Recruiting
Atlanta, Georgia, United States, 30318
AURORA Investigative Center Recruiting
Columbus, Georgia, United States, 31904
AURORA Investigative Center Recruiting
Lawrenceville, Georgia, United States, 30046
United States, Illinois
AURORA Investigative Center Recruiting
Chicago, Illinois, United States, 60637
United States, Kentucky
AURORA Investigative Center Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
AURORA Investigative Center Recruiting
Baton Rouge, Louisiana, United States, 70809
AURORA Investigative Center Recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
AURORA Investigative Center Recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
AURORA Investigative Center Recruiting
Detroit, Michigan, United States, 48201-2017
AURORA Investigative Center Recruiting
Grand Blanc, Michigan, United States, 48439
United States, Minnesota
AURORA Investigative Center Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
AURORA Investigative Center Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
AURORA Investigative Center Recruiting
Las Vegas, Nevada, United States, 89128
United States, New Jersey
AURORA Investigative Center Recruiting
Newark, New Jersey, United States, 07103
United States, New York
AURORA Investigative Center Recruiting
Great Neck, New York, United States, 11021
AURORA Investigative Center Recruiting
New York, New York, United States, 10016
AURORA Investigative Center Recruiting
New York, New York, United States, 10021-4823
AURORA Investigative Center Recruiting
New York, New York, United States, 11203
AURORA Investigative Center Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
AURORA Investigative Center Recruiting
Chapel Hill, North Carolina, United States, 27514
AURORA Investigative Center Recruiting
Charlotte, North Carolina, United States, 28204
AURORA Investigative Center Recruiting
Charlotte, North Carolina, United States, 28210
AURORA Investigative Center Recruiting
Greenville, North Carolina, United States, 27834
AURORA Investigative Center Recruiting
New Bern, North Carolina, United States, 28562
AURORA Investigative Center Withdrawn
Raleigh, North Carolina, United States, 27617
United States, Ohio
AURORA Investigative Center Recruiting
Cleveland, Ohio, United States, 44109
AURORA Investigative Center Recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
AURORA Investigative Center Recruiting
Oklahoma City, Oklahoma, United States, 73103
AURORA Investigative Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
AURORA Investigative Center Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
AURORA Investigative Center Recruiting
Chattanooga, Tennessee, United States, 37408
AURORA Investigative Center Recruiting
Hendersonville, Tennessee, United States, 37075
United States, Texas
AURORA Investigative Center Recruiting
Beaumont, Texas, United States, 77036
AURORA Investigative Center Recruiting
Dallas, Texas, United States, 75231
AURORA Investigative Center Recruiting
Dallas, Texas, United States, 75246
AURORA Investigative Center Recruiting
Dallas, Texas, United States, 75390
AURORA Investigative Center Recruiting
El Paso, Texas, United States, 79905
AURORA Investigative Center Recruiting
El Paso, Texas, United States, 79935
AURORA Investigative Center Recruiting
Houston, Texas, United States, 77030
AURORA Investigative Center Withdrawn
Pearland, Texas, United States, 77584
United States, Virginia
AURORA Investigative Center Recruiting
Arlington, Virginia, United States, 22205
AURORA Recruiting
Richmond, Virginia, United States, 23298
Argentina
AURORA Investigative Center Recruiting
Buenos Aires, Argentina
Belarus
AURORA Investigative Cener Recruiting
Minsk, Belarus, 220116
AURORA Investigative Center Recruiting
Minsk, Belarus, 223040
AURORA Investigative Center Recruiting
Vitebsk, Belarus
Brazil
AURORA Investigative Center Recruiting
Curitiba, Brazil
AURORA Investigative Center Recruiting
Porto Alegre, Brazil
AURORA Investigative Center Recruiting
Salvador, Brazil
AURORA Investigative Center Recruiting
São Paulo, Brazil
Bulgaria
AURORA Investigative Center Recruiting
Plovdiv, Bulgaria
AURORA Investigative Center Recruiting
Smolyan, Bulgaria
AURORA Investigative Center Recruiting
Sofia, Bulgaria
AURORA Investigative Center Recruiting
Stara Zagora, Bulgaria, 6001
AURORA Investigative Center Recruiting
Vidin, Bulgaria
Canada, Alberta
AURORA Investigative Center Recruiting
Edmonton, Alberta, Canada
Canada, Quebec
AURORA Investigative Center Recruiting
Montreal, Quebec, Canada
AURORA Investigative Center Recruiting
Montréal, Quebec, Canada
Canada
AURORA Investigative Center Recruiting
Toronto, Canada
Chile
AURORA Investigative Center Recruiting
Santiago, Chile
AURORA Investigative Center Recruiting
Temuco, Chile
AURORA Investigative Center Recruiting
Valdivia, Chile
Colombia
AURORA Investigative Center Recruiting
Barranquilla, Colombia
AURORA Investigative Center Recruiting
Bogotá, Colombia
AURORA Investigative Center Recruiting
Bucaramanga, Colombia
AURORA Investigative Center Recruiting
Zipaquirá, Colombia
Costa Rica
AURORA Investigative Center Recruiting
San José, Costa Rica, 10108
AURORA Investigative Center Recruiting
San José, Costa Rica
Croatia
AURORA Investigative Center Recruiting
Osijek, Croatia
AURORA Investigative Center Recruiting
Zagreb, Croatia
Dominican Republic
AURORA Investigative Center Recruiting
Santiago de los Caballeros, Dominican Republic
AURORA Investigative Center Recruiting
Santo Domingo, Dominican Republic
Guatemala
AURORA Investigative Center Recruiting
Guatemala City, Guatemala
Japan
AURORA Investigative Center Recruiting
Kita, Osaka, Japan
AURORA Investigative Center Recruiting
Chiba, Japan
AURORA Investigative Center Recruiting
Hiroshima, Japan
AURORA Investigative Center Recruiting
Ishikawa, Japan
AURORA Investigative Center Recruiting
Kitakyushu, Japan
AURORA Investigative Center Recruiting
Kita, Japan
AURORA Investigative Center Recruiting
Maebashi, Japan
AURORA Investigative Center Recruiting
Nagasaki, Japan
AURORA Investigative Center Recruiting
Niigata, Japan
AURORA Investigative Center Recruiting
Sapporo, Japan
AURORA Investigative Center Recruiting
Sendai, Japan
AURORA Investigative Center Recruiting
Tokyo, Japan
Korea, Republic of
AURORA Investigative Center Recruiting
Daejeon, Korea, Republic of
AURORA Investigative Center Recruiting
Seoul, Korea, Republic of
AURORA Investigative Center Recruiting
Suwon-si, Korea, Republic of
AURORA Investigative Center Recruiting
Wŏnju, Korea, Republic of
Macedonia, The Former Yugoslav Republic of
AURORA Investigative Center Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Malaysia
AURORA Investigative Center Recruiting
George Town, Malaysia
AURORA Investigative Center Recruiting
Kuala Lumpur, Malaysia, 50586
Mexico
AURORA Investigative Center Recruiting
Baja California, Mexico
AURORA Investigative Center Recruiting
Coahuila, Mexico
AURORA Investigative Center Recruiting
Guadalajara, Mexico
AURORA Investigative Center Recruiting
León, Mexico
AURORA Investigative Center Recruiting
Mexico City, Mexico
AURORA Investigative Center Recruiting
Monclova, Mexico
AURORA Investigative Center Recruiting
Mérida, Mexico
AURORA Investigative Center Recruiting
Oaxaca, Mexico
AURORA Investigative Center Recruiting
San Luis Potosí, Mexico
AURORA Investigative Center Recruiting
Sinaloa, Mexico
Netherlands
AURORA Investigative Center Recruiting
Amsterdam, Netherlands
AURORA Investigative Center Recruiting
Groningen, Netherlands
AURORA Investigative Center Recruiting
Leiden, Netherlands
AURORA Investigative Center Recruiting
Maastricht, Netherlands
AURORA Investigative Center Recruiting
Rotterdam, Netherlands
Peru
AURORA Investigative Center Recruiting
Lima, Peru
AURORA Investigative Center Recruiting
Trujillo, Peru
Philippines
AURORA Investigative Center Recruiting
Angeles City, Philippines
AURORA Investigative Center Recruiting
Davao City, Philippines
AURORA Investigative Center Recruiting
Lipa, Philippines
AURORA Investigative Center Recruiting
Manila, Philippines
AURORA Investigative Center Recruiting
Quezon City, Philippines
Poland
AURORA Investigative Center Recruiting
Katowice, Poland
AURORA Investigative Center Recruiting
Warszawa, Poland
AURORA Investigative Center Recruiting
Wrocław, Poland
Puerto Rico
AURORA Investigative Center Recruiting
San Juan, Puerto Rico
Russian Federation
AURORA Investigative Center Recruiting
Kazan, Russian Federation
AURORA Investigative Center Recruiting
Kemerovo, Russian Federation
AURORA Investigative Center Recruiting
Krasnoyarsk, Russian Federation
AURORA Investigative Center Recruiting
Moscow, Russian Federation
AURORA Investigative Center Recruiting
Omsk, Russian Federation
AURORA Investigative Center Recruiting
Petrozavodsk, Russian Federation
AURORA Investigative Center Recruiting
Rostov-on-Don, Russian Federation
AURORA Investigative Center Recruiting
Saint Petersburg, Russian Federation, 197110
AURORA Investigative Center Recruiting
Saint Petersburg, Russian Federation
AURORA Investigative Center Recruiting
Samara, Russian Federation
AURORA Investigative Center Recruiting
Saratov, Russian Federation
AURORA Investigative Center Recruiting
Tol'yatti, Russian Federation, 445009
AURORA Investigative Center Recruiting
Yaroslavl, Russian Federation, 150062
AURORA Investigative Center Recruiting
Yekaterinburg, Russian Federation
Serbia
AURORA Investigative Center Recruiting
Belgrade, Serbia
AURORA Investigative Center Recruiting
Niš, Serbia
South Africa
AURORA Investigative Center Recruiting
Cape town, South Africa
AURORA Investigative Center Recruiting
Johannesburg, South Africa
AURORA Investigative Center Recruiting
Pretoria, South Africa
AURORA Investigative Center Recruiting
Stellenbosch, South Africa
Spain
AURORA Investigative Center Recruiting
A Coruña, Spain
AURORA Investigative Center Recruiting
Barcelona, Spain, 08025
AURORA Investigative Center Recruiting
Madrid, Spain, 28006
AURORA Investigative Center Recruiting
Madrid, Spain, 28041
AURORA Investigative Center Recruiting
Valencia, Spain
Taiwan
AURORA Investigative Center Recruiting
Chang Hua, Taiwan
AURORA Investigative Center Recruiting
Chang-hua, Taiwan
AURORA Investigative Center Recruiting
Taichung, Taiwan
AURORA Investigative Center Recruiting
Taoyuan, Taiwan
Thailand
AURORA Investigative Center Recruiting
Bangkok, Thailand
AURORA Investigative Center Recruiting
Chiang Mai, Thailand
AURORA Investigative Center Recruiting
Songkhla, Thailand
Turkey
AURORA Investigative Center Recruiting
Balcalı, Turkey
AURORA Investigative Center Recruiting
Bursa, Turkey
AURORA Investigative Center Recruiting
Efeler, Turkey
AURORA Investigative Center Recruiting
Fatih, Turkey
AURORA Investigative Center Recruiting
İstanbul, Turkey
AURORA Investigative Center Recruiting
Konyaalti, Turkey
AURORA Investigative Center Recruiting
Malatya, Turkey
AURORA Investigative Center Recruiting
Yenimahalle, Turkey
Ukraine
AURORA Investigative Center Recruiting
Kharkiv, Ukraine, 61103
AURORA Investigative Center Recruiting
Kyiv, Ukraine, 02125
AURORA Investigative Center Recruiting
Kyiv, Ukraine
AURORA Investigative Center Recruiting
Luts'k, Ukraine
AURORA Investigative Center Recruiting
Odessa, Ukraine, 65025
AURORA Investigative Center Recruiting
Vinnytsya, Ukraine, 21018
AURORA Investigative Center Recruiting
Zaporizhzhya, Ukraine
Vietnam
AURORA Investigative Center Recruiting
Hanoi, Vietnam
AURORA Investigative Center Recruiting
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
Investigators
Principal Investigator: Mary Anne Dooley, MD, MPH University of North Carolina

Publications of Results:
Other Publications:
Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03021499     History of Changes
Other Study ID Numbers: AUR-VCS-2016-01
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aurinia Pharmaceuticals Inc.:
lupus nephritis
calcineurin inhibitors
voclosporin

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Calcineurin Inhibitors
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents