None listed
Conditions
Interventions
Orelvo – 23.7 mg (3 capsules) BID Type of group
Orelvo – 23.7 mg (3 capsules) BID
Orelvo 23.7 mg BID
3 capsules administered BID in combination with MMF and oral corticosteroids from consent onwards.
After 12 months treatment in the AURORA 2 Continuation Study (i.e., 24 months treatment in total)
Sponsors
Aurinia Pharmaceutical Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent before any study-specific procedures are performed. 2. Male or female 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. 3. In the opinion of the Investigator, subject requires continued immunosuppressive therapy. 4. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study (see Section 5.4, Adequate/Effective Contraception). 5. Subject is willing to continue taking oral MMF for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects unable or unwilling to give written informed consent and/or to comply with study procedures. 2. 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. 3. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. 4. A planned kidney transplant within study treatment period. 5. 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. 6. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions. 7. Vaccines using live organisms, virus or bacterial, while taking the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary safety endpoints are the AE profile and routine biochemical and hematological assessments at Month 36 Measure:•AE profile and routine biochemical and hematological assessments Timepoints:Month 36 visit 23 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name: The following key secondary efficacy endpoints will be analyzed using the ITT population using logistic regression with terms for treatment group, baseline UPCR, biopsy class, and MMF use at baseline (from AURORA 1) in the model Measure:• Proportion of subjects in renal response at Months 12, 18, 24, 30, and 36. • Proportion of subjects in partial renal response at Months 12, 18, 24, 30, and 36 Timepoints:Month 36 | — |
Countries
Belarus, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Dominican Republic, Guatemala, Japan, Korea North, Korea South, Macedonia, Malasya, Mexico, Netherlands, Peru, Philippines, Poland, Puerto Rico, Russian Federation, Serbia, South Africa, Spain, Sri Lanka, Taiwan, Thailand, Turkey, Ukraine, United States, Vietnam
Contacts
Public ContactDiana Gabriela De la Cueva
WorldWide Clinical Trials Peru S.R.L. -W.C.T. Peru S.R.L.
Outcome results
None listed