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Aurinia Renal Response in Active Lupus With Voclosporin (AURORA)

Primary Purpose

Lupus Nephritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Voclosporin

Placebo Oral Capsule

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring lupus nephritis, calcineurin inhibitors, voclosporin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Kidney biopsy result within 6 months prior to screening indicating Class III, IV-S or IV-G (alone or in combination with Class V) LN with a UPCR of ≥1.5 mg/mg at screening.

Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of ≥2 mg/mg at screening.
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Voclosporin

Placebo Oral Capsule

Arm Description

oral, 23.7 mg twice daily (BID)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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.

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.

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)

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

Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio

Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio

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.

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

Change From Baseline in UPCR

Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.

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

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.

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.

Full Information

NCT ID

NCT03021499

First Posted

January 12, 2017

Last Updated

March 23, 2023

Sponsor

Aurinia Pharmaceuticals Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03021499

Brief Title

Aurinia Renal Response in Active Lupus With Voclosporin

Acronym

AURORA

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 17, 2017 (Actual)

Primary Completion Date

September 24, 2019 (Actual)

Study Completion Date

October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aurinia Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Nephritis

Keywords

lupus nephritis, calcineurin inhibitors, voclosporin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

358 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Voclosporin

Arm Type

Experimental

Arm Description

oral, 23.7 mg twice daily (BID)

Arm Title

Placebo Oral Capsule

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Voclosporin

Other Intervention Name(s)

ISA247

Intervention Description

calcineurin inhibitor

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Capsule

Intervention Description

matching placebo capsule

Primary Outcome Measure Information:

Title

Number of Participants With Adjudicated Renal Response at Week 52

Description

Time Frame

52 Weeks

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

52 Weeks

Title

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

Description

Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less.

Time Frame

52 Weeks

Title

Number of Participants With Renal Response at Week 24

Description

Time Frame

Week 24

Title

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

Description

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.

Time Frame

Weeks 24 and 52

Title

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

Description

Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg)

Time Frame

Week 52

Title

Duration of Renal Response (Number of Days)

Description

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

Time Frame

Week 52

Title

Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio

Description

Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio

Time Frame

52 Weeks

Title

Time to 50% Reduction in UPCR (Number of Days)

Description

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.

Time Frame

52 weeks

Title

Change From Baseline in eGFR

Description

Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.

Title

Change From Baseline in UPCR

Description

Change from baseline by visit in Urine Protein Creatinine Ratio. Baseline is the average of two pre-randomisation values.

Time Frame

Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52.

Title

Number of Subjects With Renal Response With Low Dose Steroids

Description

Programmed Renal Response whilst on low dose steroids (<2.5 mg/day) for the preceding 8 Weeks at Weeks 24 and 52

Time Frame

Week 24 and Week 52

Title

Change From Baseline in Safety of Estrogens in Systemic Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA - SLEDAI)

Description

Time Frame

Week 24 and Week 52

Title

Change From Baseline in Patient Reported Outcomes

Description

Time Frame

Week 24 and Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samir Parikh, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

AURORA Investigative Center

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35805

Country

United States

Facility Name

AURORA Investigative Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

AURORA Investigative Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

AURORA Investigative Center

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

AURORA Investigative Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

AURORA Investigative Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

AURORA Investigative Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

AURORA Investigative Center

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360

Country

United States

Facility Name

AURORA Investigative Center

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

AURORA Investigative Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

AURORA Investigative Center

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

AURORA Investigative Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

AURORA Investigative Center

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

AURORA Investigative Center

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

AURORA Investigative Center

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33309

Country

United States

Facility Name

AURORA Investigative Center

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

AURORA Investigative Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

AURORA Investigative Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32810

Country

United States

Facility Name

AURORA Investigative Center

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

AURORA Investigative Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

AURORA Investigative Center

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

AURORA Investigative Center

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

AURORA Investigative Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

AURORA Investigative Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

AURORA Investigative Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

AURORA Investigative Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

AURORA Investigative Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

AURORA Investigative Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201-2017

Country

United States

Facility Name

AURORA Investigative Center

City

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

AURORA Investigative Center

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

AURORA Investigative Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

AURORA Investigative Center

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

AURORA Investigative Center

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103

Country

United States

Facility Name

AURORA Investigative Center

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

AURORA Investigative Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

AURORA Investigative Center

City

New York

State/Province

New York

ZIP/Postal Code

10021-4823

Country

United States

Facility Name

AURORA Investigative Center

City

New York

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

AURORA Investigative Center

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

AURORA Investigative Center

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

AURORA Investigative Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

AURORA Investigative Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

AURORA Investigative Center

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

AURORA Investigative Center

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Facility Name

AURORA Investigative Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

AURORA Investigative Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

AURORA Investigative Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

AURORA Investigative Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

AURORA Investigative Center

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

AURORA Investigative Center

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37408

Country

United States

Facility Name

AURORA Investigative Center

City

Hendersonville

State/Province

Tennessee

ZIP/Postal Code

37075

Country

United States

Facility Name

AURORA Investigative Center

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77036

Country

United States

Facility Name

AURORA Investigative Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

AURORA Investigative Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

AURORA Investigative Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

AURORA Investigative Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79905

Country

United States

Facility Name

AURORA Investigative Center

City

El Paso

State/Province

Texas

ZIP/Postal Code

79935

Country

United States

Facility Name

AURORA Investigative Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

AURORA Investigative Center

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22205

Country

United States

Facility Name

AURORA

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

AURORA Investigative Center

City

Buenos Aires

Country

Argentina

Facility Name

AURORA Investigative Center

City

Caba

Country

Argentina

Facility Name

AURORA Investigative Center

City

Córdoba

Country

Argentina

Facility Name

AURORA Investigative Center

City

La Plata

Country

Argentina

Facility Name

AURORA Investigative Center

City

San Miguel De Tucumán

Country

Argentina

Facility Name

AURORA Investigative Cener

City

Minsk

ZIP/Postal Code

220116

Country

Belarus

Facility Name

AURORA Investigative Center

City

Minsk

ZIP/Postal Code

223040

Country

Belarus

Facility Name

AURORA Investigative Center

City

Vitebsk

Country

Belarus

Facility Name

AURORA Investigative Center

City

Curitiba

Country

Brazil

Facility Name

AURORA Investigative Center

City

Porto Alegre

Country

Brazil

Facility Name

AURORA Investigative Center

City

Salvador

Country

Brazil

Facility Name

AURORA Investigative Center

City

São Paulo

Country

Brazil

Facility Name

AURORA Investigative Center

City

Plovdiv

Country

Bulgaria

Facility Name

AURORA Investigative Center

City

Smolyan

Country

Bulgaria

Facility Name

AURORA Investigative Center

City

Sofia

Country

Bulgaria

Facility Name

AURORA Investigative Center

City

Stara Zagora

ZIP/Postal Code

6001

Country

Bulgaria

Facility Name

AURORA Investigative Center

City

Vidin

Country

Bulgaria

Facility Name

AURORA Investigative Center

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

AURORA Investigative Center

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

AURORA Investigative Center

City

Montréal

State/Province

Quebec

Country

Canada

Facility Name

AURORA Investigative Center

City

Toronto

Country

Canada

Facility Name

AURORA Investigative Center

City

Santiago

Country

Chile

Facility Name

AURORA Investigative Center

City

Temuco

Country

Chile

Facility Name

AURORA Investigative Center

City

Valdivia

Country

Chile

Facility Name

AURORA Investigative Center

City

Barranquilla

Country

Colombia

Facility Name

AURORA Investigative Center

City

Bogotá

Country

Colombia

Facility Name

AURORA Investigative Center

City

Bucaramanga

Country

Colombia

Facility Name

AURORA Investigative Center

City

Zipaquirá

Country

Colombia

Facility Name

AURORA Investigative Center

City

San José

ZIP/Postal Code

10108

Country

Costa Rica

Facility Name

AURORA Investigative Center

City

San José

Country

Costa Rica

Facility Name

AURORA Investigative Center

City

Osijek

Country

Croatia

Facility Name

AURORA Investigative Center

City

Zagreb

Country

Croatia

Facility Name

AURORA Investigative Center

City

Santiago de los Caballeros

Country

Dominican Republic

Facility Name

AURORA Investigative Center

City

Santo Domingo

Country

Dominican Republic

Facility Name

AURORA Investigative Center

City

Guatemala City

Country

Guatemala

Facility Name

AURORA Investigative Center

City

Kita

State/Province

Osaka

Country

Japan

Facility Name

AURORA Investigative Center

City

Chiba

Country

Japan

Facility Name

AURORA Investigative Center

City

Hiroshima

Country

Japan

Facility Name

AURORA Investigative Center

City

Ishikawa

Country

Japan

Facility Name

AURORA Investigative Center

City

Kitakyushu

Country

Japan

Facility Name

AURORA Investigative Center

City

Kita

Country

Japan

Facility Name

AURORA Investigative Center

City

Maebashi

Country

Japan

Facility Name

AURORA Investigative Center

City

Nagasaki

Country

Japan

Facility Name

AURORA Investigative Center

City

Niigata

Country

Japan

Facility Name

AURORA Investigative Center

City

Sapporo

Country

Japan

Facility Name

AURORA Investigative Center

City

Sendai

Country

Japan

Facility Name

AURORA Investigative Center

City

Tokyo

Country

Japan

Facility Name

AURORA Investigative Center

City

Daejeon

Country

Korea, Republic of

Facility Name

AURORA Investigative Center

City

Seoul

Country

Korea, Republic of

Facility Name

AURORA Investigative Center

City

Suwon-si

Country

Korea, Republic of

Facility Name

AURORA Investigative Center

City

Wŏnju

Country

Korea, Republic of

Facility Name

AURORA Investigative Center

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

AURORA Investigative Center

City

Baja California

Country

Mexico

Facility Name

AURORA Investigative Center

City

Coahuila

Country

Mexico

Facility Name

AURORA Investigative Center

City

Guadalajara

Country

Mexico

Facility Name

AURORA Investigative Center

City

León

Country

Mexico

Facility Name

AURORA Investigative Center

City

Mexico City

Country

Mexico

Facility Name

AURORA Investigative Center

City

Monclova

Country

Mexico

Facility Name

AURORA Investigative Center

City

Mérida

Country

Mexico

Facility Name

AURORA Investigative Center

City

Oaxaca

Country

Mexico

Facility Name

AURORA Investigative Center

City

San Luis Potosí

Country

Mexico

Facility Name

AURORA Investigative Center

City

Sinaloa

Country

Mexico

Facility Name

AURORA Investigative Center

City

Amsterdam

Country

Netherlands

Facility Name

AURORA Investigative Center

City

Groningen

Country

Netherlands

Facility Name

AURORA Investigative Center

City

Leiden

Country

Netherlands

Facility Name

AURORA Investigative Center

City

Maastricht

Country

Netherlands

Facility Name

AURORA Investigative Center

City

Rotterdam

Country

Netherlands

Facility Name

AURORA Investigative Center

City

Skopje

ZIP/Postal Code

1000

Country

North Macedonia

Facility Name

AURORA Investigative Center

City

Lima

Country

Peru

Facility Name

AURORA Investigative Center

City

Trujillo

Country

Peru

Facility Name

AURORA Investigative Center

City

Angeles City

Country

Philippines

Facility Name

AURORA Investigative Center

City

Davao City

Country

Philippines

Facility Name

AURORA Investigative Center

City

Lipa

Country

Philippines

Facility Name

AURORA Investigative Center

City

Manila

Country

Philippines

Facility Name

AURORA Investigative Center

City

Quezon City

Country

Philippines

Facility Name

AURORA Investigative Center

City

Katowice

Country

Poland

Facility Name

AURORA Investigative Center

City

Warszawa

Country

Poland

Facility Name

AURORA Investigative Center

City

Wrocław

Country

Poland

Facility Name

AURORA Investigative Center

City

San Juan

Country

Puerto Rico

Facility Name

AURORA Investigative Center

City

Kazan

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Kemerovo

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Krasnoyarsk

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Moscow

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Omsk

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Petrozavodsk

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Rostov-on-Don

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Saint Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Saint Petersburg

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Samara

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Saratov

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Tol'yatti

ZIP/Postal Code

445009

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Yekaterinburg

Country

Russian Federation

Facility Name

AURORA Investigative Center

City

Belgrade

Country

Serbia

Facility Name

AURORA Investigative Center

City

Niš

Country

Serbia

Facility Name

AURORA Investigative Center

City

Cape town

Country

South Africa

Facility Name

AURORA Investigative Center

City

Johannesburg

Country

South Africa

Facility Name

AURORA Investigative Center

City

Pretoria

Country

South Africa

Facility Name

AURORA Investigative Center

City

Stellenbosch

Country

South Africa

Facility Name

AURORA Investigative Center

City

A Coruña

Country

Spain

Facility Name

AURORA Investigative Center

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

AURORA Investigative Center

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

AURORA Investigative Center

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

AURORA Investigative Center

City

Valencia

Country

Spain

Facility Name

AURORA Investigative Center

City

Chang Hua

Country

Taiwan

Facility Name

AURORA Investigative Center

City

Chang-hua

Country

Taiwan

Facility Name

AURORA Investigative Center

City

Taichung

Country

Taiwan

Facility Name

AURORA Investigative Center

City

Taoyuan

Country

Taiwan

Facility Name

AURORA Investigative Center

City

Bangkok

Country

Thailand

Facility Name

AURORA Investigative Center

City

Chiang Mai

Country

Thailand

Facility Name

AURORA Investigative Center

City

Songkhla

Country

Thailand

Facility Name

AURORA Investigative Center

City

Balcalı

Country

Turkey

Facility Name

AURORA Investigative Center

City

Bursa

Country

Turkey

Facility Name

AURORA Investigative Center

City

Efeler

Country

Turkey

Facility Name

AURORA Investigative Center

City

Fatih

Country

Turkey

Facility Name

AURORA Investigative Center

City

İstanbul

Country

Turkey

Facility Name

AURORA Investigative Center

City

Konyaalti

Country

Turkey

Facility Name

AURORA Investigative Center

City

Malatya

Country

Turkey

Facility Name

AURORA Investigative Center

City

Yenimahalle

Country

Turkey

Facility Name

AURORA Investigative Center

City

Kharkiv

ZIP/Postal Code

61103

Country

Ukraine

Facility Name

AURORA Investigative Center

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

AURORA Investigative Center

City

Kyiv

Country

Ukraine

Facility Name

AURORA Investigative Center

City

Luts'k

Country

Ukraine

Facility Name

AURORA Investigative Center

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

AURORA Investigative Center

City

Vinnytsya

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

AURORA Investigative Center

City

Zaporizhzhya

Country

Ukraine

Facility Name

AURORA Investigative Center

City

Hanoi

Country

Vietnam

Facility Name

AURORA Investigative Center

City

Ho Chi Minh City

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22879439

Citation

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.

Results Reference

background

PubMed Identifier

24330024

Citation

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.

Results Reference

background

PubMed Identifier

23996158

Citation

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.

Results Reference

background

PubMed Identifier

23736966

Citation

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.

Results Reference

background

PubMed Identifier

22087680

Citation

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.

Results Reference

result

PubMed Identifier

21943027

Citation

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.

Results Reference

result

PubMed Identifier

33971155

Citation

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.

Results Reference

derived

Learn more about this trial

Aurinia Renal Response in Active Lupus With Voclosporin

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Aurinia Renal Response in Active Lupus With Voclosporin (AURORA)

Lupus Nephritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial