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

Amgen

Status and phase: Completed; Phase 2

Conditions: Immunoglobulin A Nephropathy

Treatments: Drug: CCX168

Study type: Interventional

Funder types: Industry

Identifiers

NCT02384317

2014-003402-33 (EudraCT Number)

CL005_168

Details and patient eligibility

About

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.

Full description

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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

CCX168 (Avacopan)

Experimental group

Description:

CCX168 (Avacopan) plus stable dose of RAAS blocker

Treatment:

Drug: CCX168