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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to test safety, tolerability, and efficacy of CCX168 in reducing proteinuria in patients with Immunoglobulin A nephropathy and persistent proteinuria despite supportive therapy with a maximally tolerated RAAS blocker.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ChemoCentryx
• Treatments: Antibodies; Immunoglobulin A; Immunoglobulins

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