Trial · NCT02141672
AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)
NCT02141672, Phase 2, Completed, Aurinia Pharmaceuticals Inc.; results first posted 2021-05-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV). Trials, record NCT02141672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02141672
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)
- NCT number
- NCT02141672
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 265 participants, actual
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Conditions
- Lupus Nephritis
- Interventions
- Voclosporin High Dose, Voclosporin Low Dose, Placebo
- First posted
- 2014-05-19
- Last updated
- 2021-05-18
- Results first posted
- 2021-05-18
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Achieving Complete Renal Remission at 24 Weeks | week 24 | Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission. |
| Secondary | Number of Subjects Achieving Complete Renal Remission at 48 Weeks | Week 48 | Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission. |
| Secondary | Number of Subjects Achieving Complete Renal Remission at 24 and 48 Weeks in the Presence of Low Dose Steroids | Weeks 24 and 48 | Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission. Low-dose steroids is defined as use of ≤5 mg prednisone for 8 weeks leading up to the Week 24 visit date or for 12 weeks leading up to the Week 48 visit date. |
| Secondary | Time to Complete Remission (Number of Weeks) | week 48 | Time to Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg in the absence of rescue medication. |
| Secondary | Time to Sustained Early Complete Remission (Number of Weeks) | week 48 | Time to Sustained Complete Remission is defined as time from first dose of voclosporin/placebo to UPCR ≤ 0.5mg occurring at week 24 or earlier and sustained until week 48 in the absence of rescue medication. |
| Secondary | Number of Subjects Achieving Sustained Early Complete Remission | week 48 | Sustained early complete remission defined as complete remission that occurred on or before Week 24 and was sustained through Week 48 |
| Secondary | Time to Partial Remission (Number of Weeks) | week 48 | Time to partial Remission is defined as time from first dose of voclosporin/placebo to 50% UPCR reduction sustained until week 48 in the absence of rescue medication. |
| Secondary | Number of Subjects Achieving Partial Remission | week 48 | Partial remission is defined as a 50% reduction in UPCR from baseline at Week 24 and Week 48. |
| Secondary | Number of Subjects Achieving, and Remaining in, Complete Remission | week 48 | Sustained complete remission defined as the first occurrence of complete remission that was sustained through Week 48 |
| Secondary | Duration of Complete Remission (Number of Weeks) | week 48 | Duration of Complete Remission is defined as time of first occurrence of UPCR ≤ 0.5 mg/mg until the second increase above 0.5 mg/mg (i.e. a single occurrence above 0.5 is permitted) or use of rescue medication. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Achieving Complete Renal Remission at 24 Weeks | week 24 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Achieving Complete Renal Remission at 48 Weeks | Week 48 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Achieving Complete Renal Remission at 24 and 48 Weeks in the Presence of Low Dose Steroids | Weeks 24 and 48 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Complete Remission (Number of Weeks) | week 48 | Intent to Treat | weeks | MEDIAN |
| SECONDARY | Time to Sustained Early Complete Remission (Number of Weeks) | week 48 | Intent to Treat | weeks | MEDIAN |
| SECONDARY | Number of Subjects Achieving Sustained Early Complete Remission | week 48 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Partial Remission (Number of Weeks) | week 48 | Intent to Treat | weeks | MEDIAN |
| SECONDARY | Number of Subjects Achieving Partial Remission | week 48 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Achieving, and Remaining in, Complete Remission | week 48 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Complete Remission (Number of Weeks) | week 48 | Intent to Treat | weeks | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group93
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Achieving Complete Renal Remission at 24 Weeks | Voclosporin Low Dose | Achieved response | 29 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 24 Weeks | Voclosporin High Dose | Achieved response | 24 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 24 Weeks | Placebo | Achieved response | 17 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 24 Weeks | Voclosporin Low Dose | Did not achieve response | 60 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 24 Weeks | Voclosporin High Dose | Did not achieve response | 64 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 24 Weeks | Placebo | Did not achieve response | 71 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 48 Weeks | Voclosporin Low Dose | Achieved response | 44 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 48 Weeks | Voclosporin High Dose | Achieved response | 35 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 48 Weeks | Placebo | Achieved response | 21 | Participants | |
| Number of Subjects Achieving Complete Renal Remission at 48 Weeks | Voclosporin Low Dose | Did not achieve response | 45 | Participants |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voclosporin Low Dose | 89 | |
| Overall Study | STARTED | Voclosporin High Dose | 88 | |
| Overall Study | STARTED | Placebo | 88 | |
| Overall Study | COMPLETED | Voclosporin Low Dose | 73 | |
| Overall Study | COMPLETED | Voclosporin High Dose | 80 | |
| Overall Study | COMPLETED | Placebo | 70 | |
| Overall Study | NOT COMPLETED | Voclosporin Low Dose | 16 | |
| Overall Study | NOT COMPLETED | Voclosporin High Dose | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 18 |
Source ClinicalTrials.gov
Adverse events288
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 | Glomerular Filtration Rate Decreased | Investigations | Voclosporin Low Dose | 27 | 89 | |
| other | Glomerular Filtration Rate Decreased | Investigations | Voclosporin High Dose | 27 | 88 | |
| other | Glomerular Filtration Rate Decreased | Investigations | Placebo | 12 | 88 | |
| other | Diarrhoea | Gastrointestinal disorders | Voclosporin Low Dose | 16 | 89 | |
| other | Diarrhoea | Gastrointestinal disorders | Voclosporin High Dose | 14 | 88 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 14 | 88 | |
| other | Nausea | Gastrointestinal disorders | Voclosporin Low Dose | 16 | 89 | |
| other | Nausea | Gastrointestinal disorders | Voclosporin High Dose | 11 | 88 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 88 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Voclosporin Low Dose | 16 | 89 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voclosporin Low Dose | 10 | 89 |
| Total, all-cause mortality | Voclosporin High Dose | 2 | 88 |
| Total, all-cause mortality | Placebo | 1 | 88 |
| Total, other adverse events | Voclosporin Low Dose | 82 | 89 |
| Total, other adverse events | Voclosporin High Dose | 85 | 88 |
| Total, other adverse events | Placebo | 75 | 88 |
| Total, serious adverse events | Voclosporin Low Dose | 25 | 89 |
| Total, serious adverse events | Voclosporin High Dose | 22 | 88 |
| Total, serious adverse events | Placebo | 14 | 88 |
Source ClinicalTrials.gov
Papers3
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02141672
GET https://conductscience.org/api/trials/v1/NCT02141672/results?page=2