Primary FSGS – Aurinia Pharmaceuticals, Inc.
Aurinia Pharmaceuticals is conducting a clinical study in primary focal segmental glomerulosclerosis (FSGS) in which you may be interested.
KDIGO guidelines include calcineurin inhibitors (CNI) as a second-line option after failure to obtain renal remission with high dose steroid treatment, and as first-line treatment in patients with relative contraindications to steroids. In addition to their well-characterized immunomodulatory effects, CNIs have a direct beneficial effect on podocyte health. Both of these CNI effects could be beneficial in the treatment of FSGS.
Voclosporin (VCS) is a novel CNI currently under development in FSGS, lupus nephritis (LN) and dry eye syndrome. Voclosporin is not commercially available and is not approved for use by any national or foreign drug regulatory authority. Over 2000 people (healthy volunteers, kidney transplant, psoriasis, uveitis and lupus nephritis) have taken voclosporin in clinical trials. Voclosporins’ safety profile to date is consistent with expectations for a calcineurin inhibitor used in these patient populations.
The aim of the current study is to investigate whether VCS monotherapy is able to reduce disease activity in treatment naïve patients over a treatment period of 24 weeks. Subjects with histologic evidence of primary FSGS with proteinuria will be eligible to enter the study. Efficacy will be assessed by the ability of VCS to reduce the level of proteinuria (as measured by UPCR) while demonstrating an acceptable safety profile. The primary endpoint of this study will be complete or partial remission of proteinuria at 24 weeks.
Aurinia Pharmaceuticals will also provide support for subjects to assist with transportation to sites conducting this trial.
- Primary FSGS diagnosis by renal biopsy within 4 months prior to the end of screening
- Male or Female 18-75 years old
- UPCR > 3.0mg/mg
- Serum albumin < 3.2mg/dL
- Treatment naïve (not received systemic steroids, cytotoxic or immunosuppressant treatment or require these treatments during the study)
- Clinical or histologic evidence of secondary FSGS, or collapsing variant FSGS
- BMI > 40kg/m2
- Previous renal transplant or planned renal transplant during the study
- GFR < 30/mL/min/1.73m2
- Currently requiring renal dialysis