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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:12/21/2016
Start Date:February 2015
End Date:December 2016

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

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.


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
We found this trial at
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