Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade

An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Immunoglobulin A Nephropathy on Stable RAAS Blockade

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Key Inclusion Criteria:

• Diagnosis of Immunoglobulin A nephropathy
• estimated glomerular filtration rate >60 mL/min/1.73 m2
• Proteinuria (first morning urinary protein:creatinine ratio >1g/g creatinine)

Key Exclusion Criteria:

• Severe renal disease
• Pregnant or nursing
• Proteinuria >8g/g creatinine or >8g/day
• Systemic manifestations of Henoch-Schonlein purpura within 2 years prior
• Patients with Immunoglobulin A nephropathy deemed secondary to underlying disease
• Biopsy reported severe crescentic Immunoglobulin A nephropathy
• History of treatment with glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior
• History of clinically significant cardiac conditions
• History of cancer within 5 years prior
• Any infection requiring antibiotic treatment that has not cleared prior to study start