Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin (AURORA2)
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|ClinicalTrials.gov Identifier: NCT03597464|
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Drug: Voclosporin Drug: Placebo Oral Capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||227 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||AURORA 2: Aurinia Renal Response in Lupus With Voclosporin|
|Actual Study Start Date :||June 12, 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Calcineurin inhibitor, oral, 23.7 mg BID
Other Name: ISA247
Placebo Comparator: Placebo Oral Capsule
Drug: Placebo Oral Capsule
Voclosporin placebo, oral, 3 capsules BID
- Adverse events (AE) profile and routine biochemical and hematological assessments. [ Time Frame: 36 months ]Adverse events (AE) profile and routine biochemical and hematological assessments.
- Proportion of subjects in renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]Proportion of subject in renal response
- Proportion of subjects in partial renal response [ Time Frame: Months 12, 18, 24, 30 and 36 ]50% reduction in baseline UPCR.
- Renal flare as adjudicated by the Clinical Endpoints Committee (CEC). [ Time Frame: Up to 37 months ]Renal flare and extra-renal flare
- Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) [ Time Frame: Months 18, 24 and 36 ]Assessment of Systemic Lupus Erythematosus (SLE) Disease Activity within the last 10 days. It scores 24 disease descriptors across 9 organ systems which are summed to a minimum of <2 (considered indicative of no activity) and maximum of 105 points. Scores are weighted and a score of 6 is considered clinically significant. Higher scores indicate worse disease activity.
- Change in Urine Protein to Creatinine Ratio (UPCR) [ Time Frame: Up to 37 months ]Change from Aurinia Renal Response in Active Lupus With Voclosporin (AURORA) 1 baseline.
- Change in estimated glomerular filtration rate (eGFR) [ Time Frame: Up to 37 months ]Change from AURORA 1 baseline.
- Change in urine protein [ Time Frame: Up to 37 months ]Change from AURORA 1 baseline.
- Change in serum creatinine [ Time Frame: Up to 37 months ]Change from AURORA 1 baseline.
- Change in immunology (Complement 3 (C3)) parameters from AURORA 1 baseline. [ Time Frame: Up to 37 months ]Complement C3: mg/dL
- Change in immunology parameters (complement 4 (C4)) from AURORA 1 baseline. [ Time Frame: Up to 37 months ]Complement C4: mg/dL
- Change in immunology parameters (anti-double-stranded deoxyribonucleic acid) from AURORA 1 baseline. [ Time Frame: Up to 37 months ]Anti-double stranded DNA: IU/mL
- Change Health Related Quality of Life Assessments (HRQoL) Short Form Health Survey (SF-36) [ Time Frame: Months 18,24,30,36 ]A set of 36 generic questions assessing quality of life and health status across 8 health concepts (physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions) and is reliant upon patient self-reporting.
- Healthcare Resource Utilization (HRU) [ Time Frame: Months 12, 15, 18, 21, 24, 27, 30, 33, 36 ]Qualitative information gathered form the subjects via interview related to utilisation of healthcare resources e.g visits to health care practitioners
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): NCT03597464
|Contact: Antonia Coeshallfirstname.lastname@example.org|
|Contact: Laura Lisk||44(0)email@example.com|
|United States, Oklahoma|
|AURORA Investigative Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|