Trial · NCT03597464
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
NCT03597464, Phase 3, Completed, Aurinia Pharmaceuticals Inc.; results first posted 2022-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin. Trials, record NCT03597464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03597464
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
- NCT number
- NCT03597464
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 216 participants, actual
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Conditions
- Lupus Nephritis
- Interventions
- Voclosporin, Placebo Oral Capsule
- First posted
- 2018-07-24
- Last updated
- 2022-12-14
- Results first posted
- 2022-12-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Month 12 (AURORA 2 baseline) to Month 36 | Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN. |
| Secondary | Number (and Percent) of Subjects in Renal Response | Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36 | Proportion of subjects in renal response defined as: * urine protein creatinine ratio (UPCR) of ≤0.5 mg/mg * estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m\^2 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 the 8 weeks prior to the renal response assessment. |
| Secondary | Number (and Percent) of Subjects in Partial Renal Response | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | Partial renal response defined as a 50% reduction from baseline in urine protein creatinine ratio (UPCR). |
| Secondary | Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC). | Month 12 (AURORA 2 baseline) to Month 36 | A patient could experience a flare from the point they achieved a response (or recovery). Renal flares were judged according to the following criteria: * A reproducible increase to UPCR \>1 mg/mg from a post-response baseline of \<0.2 mg/mg or * an increase to UPCR \>2 mg/mg from a post-response baseline between 0.2 to 1.0 mg/mg or * a doubling of UPCR for baseline values of UPCR \>1 mg/mg |
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) | Months 18, 24 and 36 | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. 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. |
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in UPCR are indicative of better renal outcomes. |
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. This endpoint incorporated Corrected eGFR values with a ceiling set to 90 mL/min/1.73 m\^2 Increases in eGFR levels are indicative of better renal outcomes. |
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Reductions in Urine Protein levels are indicative of better renal outcomes. |
| Secondary | Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | Participants analyzed included all subjects who were randomized treatment during AURORA 1 AND who consented to continue their treatment in AURORA 2. Baseline values were collected at the start of AURORA 1 but only for those subjects that continued in AURORA 2. Decreases in SCr levels can be indicative of better renal outcomes. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Month 12 (AURORA 2 baseline) to Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number (and Percent) of Subjects in Renal Response | Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number (and Percent) of Subjects in Partial Renal Response | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC). | Month 12 (AURORA 2 baseline) to Month 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) | Months 18, 24 and 36 | The number of subjects analyzed may not be aligned with overall number analyzed due to subjects withdrawing from study and missed study visits | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | mg/mg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) | Months 12 (AURORA 2 baseline), 18, 24, 30 and 36 | The number of subjects analyzed may not be aligned with overall number analyzed due to early withdrawals from study and missed study visits | mg/dL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Voclosporin | Any treatment-emergent adverse event (TEAE) | 100 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Placebo Oral Capsule | Any treatment-emergent adverse event (TEAE) | 80 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Voclosporin | Treatment-related TEAE | 28 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Placebo Oral Capsule | Treatment-related TEAE | 21 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Voclosporin | Serious TEAE | 21 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Placebo Oral Capsule | Serious TEAE | 23 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Voclosporin | TEAE leading to study drug discontinuation | 11 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Placebo Oral Capsule | TEAE leading to study drug discontinuation | 17 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Voclosporin | TEAE leading to death | 0 | Participants | |
| Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. | Placebo Oral Capsule | TEAE leading to death | 3 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voclosporin | 116 | |
| Overall Study | STARTED | Placebo Oral Capsule | 100 | |
| Overall Study | COMPLETED | Voclosporin | 101 | |
| Overall Study | COMPLETED | Placebo Oral Capsule | 85 | |
| Overall Study | NOT COMPLETED | Voclosporin | 15 | |
| Overall Study | NOT COMPLETED | Placebo Oral Capsule | 15 |
Source ClinicalTrials.gov
Adverse events126
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Voclosporin | 14 | 116 | 22 |
| other | Urinary tract infection | Infections and infestations | Placebo Oral Capsule | 8 | 100 | 10 |
| other | Upper respiratory tract infection | Infections and infestations | Voclosporin | 10 | 116 | 11 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Oral Capsule | 3 | 100 | 6 |
| other | Viral upper respiratory tract infection | Infections and infestations | Voclosporin | 10 | 116 | 10 |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo Oral Capsule | 4 | 100 | 6 |
| other | Bronchitis | Infections and infestations | Voclosporin | 5 | 116 | 5 |
| other | Bronchitis | Infections and infestations | Placebo Oral Capsule | 4 | 100 | 4 |
| other | Corona virus infection | Infections and infestations | Voclosporin | 5 | 116 | 6 |
| other | Corona virus infection | Infections and infestations | Placebo Oral Capsule | 8 | 100 | 9 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voclosporin | 0 | 116 |
| Total, all-cause mortality | Placebo Oral Capsule | 3 | 100 |
| Total, other adverse events | Voclosporin | 84 | 116 |
| Total, other adverse events | Placebo Oral Capsule | 60 | 100 |
| Total, serious adverse events | Voclosporin | 21 | 116 |
| Total, serious adverse events | Placebo Oral Capsule | 23 | 100 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Voclosporin vs Placebo Oral Capsule: deaths from any cause | Trial comparisons |
| Voclosporin vs Placebo Oral Capsule: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03597464
GET https://conductscience.org/api/trials/v1/NCT03597464/results?page=2