SLCTR/2015/001
Completed
Phase 2
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
ConditionsActive Lupus Nephritis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Active Lupus Nephritis
- Sponsor
- Aurinia Pharmaceuticals Inc.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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A clinical study to assess the efficacy of Orelvo (voclosporin) compared with placebo in achieving renal response after 24 weeks of therapy in subjects with active lupus nephritis (LN)Active Lupus NephritisMedDRA version: 19.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2016-004045-81-ESAurinia Pharmaceuticals, Inc.324