ROCKVILLE, Maryland and EDMONTON, Alberta, July 6, 2026
Aurinia Pharmaceuticals Inc. announced the initiation of PRESERVE, a Phase 4, multicenter clinical study evaluating the combination of LUPKYNIS® (voclosporin) with belimumab, obinutuzumab, or anifrolumab in patients with lupus nephritis (LN). The study is expected to enroll approximately 150 patients across nearly 50 clinical sites in the United States, with the primary endpoint measuring the proportion of participants achieving Complete Renal Response (CRR) after six months of treatment.
Study Evaluates Complementary Mechanisms to Improve Kidney Outcomes
The PRESERVE study is designed to investigate whether combining LUPKYNIS, the only FDA-approved oral therapy for lupus nephritis, with biologic therapies targeting different immune pathways can further improve clinical outcomes in patients with this serious autoimmune kidney disease. LUPKYNIS works by stabilizing podocytes and suppressing T-cell activation, while belimumab inhibits B-cell activating factor (BAFF), obinutuzumab targets CD20-positive B cells, and anifrolumab blocks type I interferon receptor signaling. By simultaneously targeting multiple non-overlapping pathways involved in lupus nephritis, researchers aim to reduce ongoing kidney damage more effectively and improve long-term preservation of kidney function.
Multitarget Therapy Addresses Persistent Unmet Need in Lupus Nephritis
Despite recent therapeutic advances, many patients with lupus nephritis continue to experience incomplete responses and progressive kidney damage. According to recently updated American College of Rheumatology treatment guidelines, rapidly reducing proteinuria, a key indicator of kidney injury, remains a primary treatment goal. Investigators noted that although several new therapies have become available, most patients still fail to achieve complete renal response within six months, and many continue to have active disease even after one year of treatment. The PRESERVE study seeks to determine whether combining complementary therapeutic mechanisms can increase complete renal response rates and improve long-term clinical outcomes.
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LUPKYNIS Continues to Expand Its Clinical Evidence Base
LUPKYNIS (voclosporin) remains the only FDA-approved oral therapy specifically indicated for adults with active lupus nephritis and the only approved treatment that has demonstrated a statistically significant improvement in complete renal response after six months of therapy. Through the PRESERVE trial, Aurinia Pharmaceuticals aims to further strengthen the clinical evidence supporting multitarget treatment strategies for lupus nephritis while addressing an area of significant unmet medical need. Beyond LUPKYNIS, the company is also advancing aritinercept, a dual inhibitor of BAFF and APRIL, for the potential treatment of additional autoimmune diseases, reinforcing its commitment to developing innovative therapies for immune-mediated disorders.
Source: Aurinia Pharmaceuticals press release
