Clinical study comparing the efficacy in the achievement of the remission (measured as reduction of proteinuria) and safety of two different doses of voclosporin and non active drug (placebo) in patients suffering from active lupus nephritis

Phase 2

• Conditions: Active Lupus Nephritis

• Registration Number: SLCTR/2015/001
• Lead Sponsor: Aurinia Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete: follow up complete
• Sex: Not specified
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of subjects achieving complete remission at 24 Weeks. <br><br>Complete remission is defined as: Confirmed protein/creatinine ratio of ?0.5 mg/mg and no confirmed decrease from baseline in eGFR of ?20%. Subjects who receive rescue medication for lupus or ?10 mg prednisone after Week 16 will not be considered as achieving complete remission.<br> [Week 24 ]<br>