A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Achieving Renal Response in Subjects with Active Lupus Nephritis - AURORA (AURinia Orelvo Renal Assessments) 1: Aurinia Renal Response in Active Lupus with Voclosporin

Aurinia Pharmaceuticals, Inc.0 sites324 target enrollmentAugust 22, 2017

Conditionsupus Nephritis MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: upus Nephritis
Sponsor: Aurinia Pharmaceuticals, Inc.
Enrollment: 324
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 22, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Aurinia Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

•Written informed consent before any study specific procedures are performed.
•Male or female subjects with a minimum age of 18 (or legal age of consent if \>18 years) to 75 years of age, inclusive, at the time of screening (Visit 1\).
•Previous diagnosis of SLE according to the American College of Rheumatology criteria
•Subjects with evidence of active nephritis, defined as follows:
•\- Kidney biopsy result within 2 years prior to screening indicating Class III, IV S, IV\-G (alone or in combination with Class V), or Class V LN (see Appendix 3\) with a doubling or greater increase of urine protein creatinine ratio (UPCR) within the last 6 months to a minimum of \=1\.5 mg/mg for Class III/IV or to a minimum of \=2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility.
•\- Kidney biopsy result within 6 months prior to screening indicating Class III, IV S or IV\-G (alone or in combination with Class V) LN with a UPCR of \=1\.5 mg/mg at screening.
•\- Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of \=2 mg/mg at screening.
•A biopsy can be performed during screening, if not available. The above criteria must be fulfilled at baseline.
•In the opinion of the Investigator, subject requires high\-dose corticosteroids and immunosuppressive therapy.
•Subject is willing to take oral MMF for the duration of the study, either by continuing current MMF therapy or by initiating it on or before the Baseline Visit.

Exclusion Criteria

•Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
•Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of \=45 mL/minute/1\.73 m2 at screening confirmed before randomization.
•Currently taking or known need for any of the medications listed in protocol Section 7\.8, Prohibited Therapy and Concomitant Treatment at screening or during the study. This includes prohibited medications prior to screening as specified in protocol Section 7\.8\.1, Prohibited Medications.
•Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
•A previous kidney transplant or planned transplant within study treatment period.
•Any known hypersensitivity or contraindication to MMF, mycophenolic acid, cyclosporine, corticosteroids or any components of these drug products.
•Current or medical history of:
•\- Congenital or acquired immunodeficiency.
•\- In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
•\- Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed.