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 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Male or female subjects aged 18 to 75 years inclusive at the time of screening.
•2. Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 7)
•3. Kidney biopsy within 6 months prior to screening (Visit I) with a histologic diagnosis of lupus nephritis (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.
•4.Subjects with laboratory evidence of active nephritis at screening, defined as follows:
•Class III, IV-S or IV-G: Confirmed proteinuria ? 1,500 mg/24 hours when assessed by 24- hour urine collection, defined by a urine protein/creatinine ratio (UPCR) of ?1.5 mg/mg assessed in a first morning void urine specimen (2 samples).
•Class V (alone or in combination with class III or IV) Confirmed proteinuria ?2,000 mg/24 hours when assessed by 24-hour urine collection, defined by a UPCR of ?2 mg/mg assed in a first morning void urine collection specimen (2 samples)

•1. Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of <45 mL/min/1.73 m2.
•2. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
•3. A previous kidney transplant or planned transplant within study treatment period.
•4. In the opinion of the Investigator, subject does not require long-term immunosuppressive treatment (in addition to corticosteroids).

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