Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
Overview
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 Title of Study: “An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Immunoglobulin A Nephropathy on Stable RAAS Blockade”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 13, 2015
Interventions
- Drug: CCX168
- CCX168 30 mg, twice daily (b.i.d.) orally for 84 days (12 weeks). The CCX168 dose was taken in the morning, optimally within one hour after breakfast, and in the evening, optimally within one hour after dinner.
Arms, Groups and Cohorts
- Experimental: CCX168 (Avacopan)
- CCX168 (Avacopan) plus stable dose of RAAS blocker
Clinical Trial Outcome Measures
Primary Measures
- Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period
- Time Frame: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)
- The mean change in the slope of the urinary protein:creatinine ratio (UPCR, in mg/g/week) between the 8-week run-in period and the 12-week treatment period
- Number of Participants With AE’s
- Time Frame: Day 0 – Day 169 (throughout the trial)
- Acronyms use: Adverse Events (AE’s) Serious Adverse Events (SAE’s)
- Severity of Adverse Events (AE’s)
- Time Frame: Day 0 – Day 169 (throughout the trial)
- Acronyms use: Adverse Events (AE’s) Serious Adverse Events (SAE’s)
Secondary Measures
- Proportion of Subjects Achieving Renal Response From Baseline to Day 85
- Time Frame: Baseline and Day 85
- Renal Response defined as an improvement in proteinuria based on a decrease from baseline to Day 85 in proteinuria to a level <300 mg/g creatinine and maintaining eGFR within 15% of baseline.
- Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85
- Time Frame: Baseline and Day 85
- A partial renal response, defined as an improvement in proteinuria based on a decrease from baseline to Day 85 in proteinuria to a level <1 g/g creatinine and maintaining eGFR within 15% of baseline.
- Change From Baseline to Day 85 in Vital Signs
- Time Frame: Baseline to day 85
- Change in Systolic Blood Pressure From Baseline to Day 85
- Time Frame: Baseline to day 85
- Change in Diastolic Blood Pressure From Baseline to Day 85
- Time Frame: Baseline to day 85
- Change in Temperature From Baseline to Day 85
- Time Frame: Baseline to day 85
- Change in Weight From Baseline to Day 85
- Time Frame: Baseline to day 85
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- ChemoCentryx
- Provider of Information About this Clinical Study
- Sponsor
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