An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis
Voclosporin is a novel calcineurin inhibitor (CNI) intended for use in the prevention of organ graft rejection and for the treatment of autoimmune diseases. The aim of the current development program is to investigate whether voclosporin added to the standard of care treatment in active Lupus Nephritis (LN) is able to reduce disease activity, as measured by a reduction in proteinuria. The background therapy will be mycophenolate mofetil (MMF) 2 g daily, initial treatment with IV methylprednisolone followed by a reducing course of oral corticosteroids. Patients with active, flaring LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria (American College of Rheumatology) and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria while demonstrating an acceptable safety profile.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
AURION Site
Kuala Lumpur, Malaysia
AURION Site
Kuala Lumpur, Malaysia
Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR)
Time frame: 24 weeks
Number of Participants With Reduction or Normalization of Anti ds DNA
Time frame: 24 weeks
Number of Participants With Reduction or Normalization of C3
Time frame: 24 weeks
Number of Participants With Reduction or Normalization of C4
Time frame: 24 weeks
Number of Participants With Complete Remission at Week 24
* Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20%
Time frame: week 24
Number of Participants With Complete Remission at Week 48
* Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20% Safety Population - 2 subjects failed to provide sufficient data to ascertain week 48 response
Time frame: week 48
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