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

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

From Baseline up to 169 days