Phase 3
Completed N=216
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
Lupus Nephritis
Source: ClinicalTrials.gov NCT03597464 ↗
Enrolled (actual)
216
Serious AEs
20.4%
Results posted
Dec 2022
Primary outcomePrimary: Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. — 100; 80; 28; 21 Participants
◆ Published Evidence
Established
31citations · ~10 / year
Management of Lupus Nephritis: New Treatments and Updated Guidelines.
Summary
The purpose of this study is 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 lupus nephritis (LN).
Linked Publications
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Management of Lupus Nephritis: New Treatments and Updated Guidelines.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments. |
100; 80; 28; 21; 21; 23 | — |
| SECONDARY Number (and Percent) of Subjects in Renal Response |
61; 34; 74; 46; 65; 43 | 0.004 sig |
| SECONDARY Number (and Percent) of Subjects in Partial Renal Response |
104; 70; 96; 68; 90; 58 | <0.001 sig |
| SECONDARY Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC). |
39; 46; 77; 54 | 0.045 sig |
| 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) |
-6.4; -5.6; -6.8; -6.1; -6.8; -6.1 | 0.238 |
| SECONDARY Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR) |
-3.17; -2.52; -3.05; -2.42; -3.18; -2.41 | 0.001 sig |
| SECONDARY Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR) |
1.8; 4.4; -0.2; 1.6; -1.3; 0.9 | 0.041 sig |
| SECONDARY Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein |
-302.4; -234.6; -297.8; -210.1; -295.8; -248.8 | 0.002 sig |
| SECONDARY Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr) |
0.051; -0.034; 0.078; 0.027; 0.117; 0.060 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
- Written informed consent before any study-specific procedures were performed.
- In the opinion of the investigator, subject required continued immunosuppressive therapy.
- Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
- Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study.
Exclusion Criteria
- Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
- Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- A planned kidney transplant within study treatment period.
- Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
- Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
- Vaccines using live organisms, virus or bacterial, while taking the study treatment.
Data sourced from ClinicalTrials.gov (NCT03597464) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.