Trial · NCT03021499
Aurinia Renal Response in Active Lupus With Voclosporin
NCT03021499, Phase 3, Completed, Aurinia Pharmaceuticals Inc.; results first posted 2021-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aurinia Renal Response in Active Lupus With Voclosporin. Trials, record NCT03021499. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03021499
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aurinia Renal Response in Active Lupus With Voclosporin
- NCT number
- NCT03021499
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 358 participants, actual
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Conditions
- Lupus Nephritis
- Interventions
- Voclosporin, Placebo Oral Capsule
- First posted
- 2017-01-16
- Last updated
- 2023-03-27
- Results first posted
- 2021-06-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adjudicated Renal Response at Week 52 | 52 Weeks | 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 | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less | 52 Weeks | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less |
| Secondary | Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days) | 52 Weeks | Time in days to reduction in Urine Protein Creatinine Ratio to decrease to 0.5 mg/mg or less. |
| Secondary | Number of Participants With Renal Response at Week 24 | 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. |
| Secondary | Number of Subjects With Partial Renal Response at Weeks 24 & 52 | Weeks 24 and 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. |
| Secondary | Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg) | Week 52 | Number of subjects achieving, and remaining in, renal response (Urine Protein Creatinine ratio ≤0.5 mg/mg) |
| Secondary | Duration of Renal Response (Number of Days) | Week 52 | 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 |
| Secondary | Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio | 52 Weeks | Number of subjects achieving 50% reduction in Urine Protein Creatinine ratio |
| Secondary | Time to 50% Reduction in UPCR (Number of Days) | 52 weeks | 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. |
| Secondary | Change From Baseline in eGFR | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Change from baseline by visit in estimated Glomerular Filtration rate. eGFR is corrected to a maximum value of 90 mL/min/1.73 m2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adjudicated Renal Response at Week 52 | 52 Weeks | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less | 52 Weeks | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days) | 52 Weeks | Intent to Treat | days | MEDIAN |
| SECONDARY | Number of Participants With Renal Response at Week 24 | Week 24 | intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Partial Renal Response at Weeks 24 & 52 | Weeks 24 and 52 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Achieving, and Remaining in, Renal Response (Urine Protein Creatinine Ratio ≤0.5 mg/mg) | Week 52 | Intent to Treat population achieving UPCR \<0.5 mg/mg | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Renal Response (Number of Days) | Week 52 | Intent to Treat | days | MEDIAN |
| SECONDARY | Number of Subjects Achieving 50% Reduction in Urine Protein Creatinine Ratio | 52 Weeks | Intent-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to 50% Reduction in UPCR (Number of Days) | 52 weeks | Intent to Treat | days | MEDIAN |
| SECONDARY | Change From Baseline in eGFR | Baseline and Weeks 2, 4, 8, 12, 16, 16, 20, 24, 30, 36, 42, 48 and 52. | Intent to Treat | ml/min/1.73 square metres | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adjudicated Renal Response at Week 52 | Voclosporin | Number of renal responders | 73 | Participants | |
| Number of Participants With Adjudicated Renal Response at Week 52 | Placebo Oral Capsule | Number of renal responders | 40 | Participants | |
| Number of Participants With Adjudicated Renal Response at Week 52 | Voclosporin | Number of renal non-responders | 106 | Participants | |
| Number of Participants With Adjudicated Renal Response at Week 52 | Placebo Oral Capsule | Number of renal non-responders | 138 | Participants | |
| Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less | Voclosporin | Subjects with UPCR ≤ 0.5 | 116 | Participants | |
| Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less | Placebo Oral Capsule | Subjects with UPCR ≤ 0.5 | 78 | Participants | |
| Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less | Voclosporin | Subjects without UPCR ≤ 0.5 | 63 | Participants | |
| Number of Participants With Reduction in Urine Protein Creatinine Ratio to 0.5 mg/mg or Less | Placebo Oral Capsule | Subjects without UPCR ≤ 0.5 | 100 | Participants | |
| Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days) | Voclosporin | 169 | 95% Confidence Interval 141 to 214 | days | |
| Time to Urine Protein Creatinine Ratio of ≤0.5 mg/mg (Number of Days) | Placebo Oral Capsule | 372 | 95% Confidence Interval 295 to NA | days |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voclosporin | 179 | |
| Overall Study | STARTED | Placebo | 178 | |
| Overall Study | Week 24 | Voclosporin | 167 | |
| Overall Study | Week 24 | Placebo | 162 | |
| Overall Study | Week 52 | Voclosporin | 162 | |
| Overall Study | Week 52 | Placebo | 147 | |
| Overall Study | COMPLETED | Voclosporin | 163 | |
| Overall Study | COMPLETED | Placebo | 147 | |
| Overall Study | NOT COMPLETED | Voclosporin | 16 | |
| Overall Study | NOT COMPLETED | Placebo | 31 |
Source ClinicalTrials.gov
Adverse events180
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 | Upper respiratory tract infection | Infections and infestations | Voclosporin | 31 | 178 | 44 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Oral Capsule | 26 | 178 | 33 |
| other | Viral upper respiratory tract infection | Infections and infestations | Voclosporin | 20 | 178 | 24 |
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo Oral Capsule | 18 | 178 | 20 |
| other | Urinary tract infection | Infections and infestations | Voclosporin | 17 | 178 | 25 |
| other | Urinary tract infection | Infections and infestations | Placebo Oral Capsule | 13 | 178 | 14 |
| other | Herpes zoster | Infections and infestations | Voclosporin | 13 | 178 | 13 |
| other | Herpes zoster | Infections and infestations | Placebo Oral Capsule | 9 | 178 | 9 |
| other | Influenza | Infections and infestations | Voclosporin | 12 | 178 | 15 |
| other | Influenza | Infections and infestations | Placebo Oral Capsule | 10 | 178 | 12 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voclosporin | 1 | 178 |
| Total, all-cause mortality | Placebo Oral Capsule | 5 | 178 |
| Total, other adverse events | Voclosporin | 161 | 178 |
| Total, other adverse events | Placebo Oral Capsule | 156 | 178 |
| Total, serious adverse events | Voclosporin | 37 | 178 |
| Total, serious adverse events | Placebo Oral Capsule | 38 | 178 |
Source ClinicalTrials.gov
Papers9
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/NCT03021499
GET https://conductscience.org/api/trials/v1/NCT03021499/results?page=2