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 |
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.
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
6
sites
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