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Trial record 1 of 9 for:    aurinia
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Aurinia Renal Response in Active Lupus With Voclosporin (AURORA)

This study is currently recruiting participants.
Verified November 2017 by Aurinia Pharmaceuticals Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03021499
First Posted: January 16, 2017
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Aurinia Pharmaceuticals Inc.
  Purpose
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 Intervention Phase
Lupus Nephritis Drug: Voclosporin Drug: Placebo Oral Capsule Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Aurinia Pharmaceuticals Inc.:

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


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

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

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

  • Renal response at Week 52 [ Time Frame: 52 Weeks ]
    Renal response at Week 52

  • Duration of renal response [ Time Frame: 52 Weeks ]
    Duration of renal response

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

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

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

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


Estimated Enrollment: 324
Actual Study Start Date: May 17, 2017
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
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, 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
Thousand Oaks, California, United States, 91360
United States, Colorado
AURORA Investigative Center Recruiting
Denver, Colorado, United States, 80218
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 Recruiting
Hialeah, Florida, United States, 33016
AURORA Investigative Center Recruiting
Miami, Florida, United States, 33125
AURORA Investigative Center Recruiting
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
Columbus, Georgia, United States, 31904
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, Michigan
AURORA Investigative Center Recruiting
Grand Blanc, Michigan, United States, 48439
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
United States, North Carolina
AURORA Investigative Center Recruiting
Chapel Hills, 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 Recruiting
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, 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
Houston, Texas, United States, 77030
AURORA Investigative Center Recruiting
Pearland, Texas, United States, 77584
United States, Virginia
AURORA Investigative Center Recruiting
Arlington, Virginia, United States, 22205
AURORA Recruiting
Richmond, Virginia, United States, 23298
Belarus
AURORA Investigative Cener Recruiting
Minsk, Belarus, 220116
AURORA Investigative Center Recruiting
Minsk, Belarus, 223040
AURORA Investigative Center Recruiting
Vitebsk, Belarus
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, Quebec
AURORA Investigative Center Recruiting
Montreal, Quebec, Canada
AURORA Investigative Center Recruiting
Montréal, Quebec, Canada
Chile
AURORA Investigative Center Recruiting
Santiago, Chile
AURORA Investigative Center Recruiting
Temuco, Chile
AURORA Investigative Center Recruiting
Valdivia, Chile
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
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
Hiroshima, Japan
AURORA Investigative Center Recruiting
Ishikawa, 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
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
Netherlands
AURORA Investigative Center Recruiting
Amsterdam, Netherlands
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
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
Omsk, Russian Federation
AURORA Investigative Center Recruiting
Petrozavodsk, Russian Federation
AURORA Investigative Center Recruiting
Saint Petersburg, Russian Federation, 197110
AURORA Investigative Center Recruiting
Saint Petersburg, 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
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
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
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
Bursa, Turkey
AURORA Investigative Center Recruiting
Efeler, 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
Sponsors and Collaborators
Aurinia Pharmaceuticals Inc.
Investigators
Principal Investigator: Mary Anne Dooley, MD, MPH University of North Carolina
  More Information

Publications:

Responsible Party: Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03021499     History of Changes
Other Study ID Numbers: AUR-VCS-2016-01
First Submitted: January 12, 2017
First Posted: January 16, 2017
Last Update Posted: November 16, 2017
Last Verified: November 2017
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