A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg BID, or 39.5 mg BID) with Placebo in Achieving Remission in Patients with Active Lupus Nephritis

Aurinia Pharmaceuticals Inc.0 sites258 target enrollmentAugust 12, 2014

Overview

No summary available.

Registry

who.int

Start Date

August 12, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Written informed consent (by subject or legally acceptable representative) before any study\-specific procedures are performed.
•2\. Male or female subjects aged 18 to 75 years inclusive at the time of consent.
•3\. Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 7\).
•4\. Kidney biopsy within 6 months prior to screening (Visit 1\) with a
•histologic diagnosis of lupus nephritis (International Society of
•Nephrology/Renal Pathology Society 2003 classification of lupus
•nephritis) Classes III, IV\-S or IV\-G, (A) or (A/C); or Class V, alone or in
•combination with Class III or IV; see Appendix 5\. If a subject has not
•had a recent kidney biopsy, one may be performed to assess eligibility
•into the study provided consent is in place and provided results are

•1\. Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
•2\. Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of \=45 mL/min/1\.73 m2 at screening (Visit 1\)
•3\. Currently taking or known need for any of the medications listed in Section 7\.8, Prohibited Therapy and Concomitant Treatment, page 58\.
•4\. Serum potassium \>5\.5 mmol/L at screening confirmed before randomization.
•5\. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
•6\. A previous kidney transplant or planned transplant within study treatment period.
•7\. In the opinion of the Investigator, subject does not require long\-term immunosuppressive treatment (in addition to corticosteroids).
•8\. Any known hypersensitivity or contraindication to MMF, mycophenolic acid, cyclosporine, corticosteroids or any components of these drug products.
•9\. Current or medical history of:
•Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.