Back to resultsOpen-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
Primary Purpose
Immunoglobulin A Nephropathy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CCX168
Sponsored by
About this trial
This is an interventional treatment trial for Immunoglobulin A Nephropathy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CCX168 (Avacopan)
Arm Description
CCX168 (Avacopan) plus stable dose of RAAS blocker
Outcomes
Primary Outcome 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
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
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Severity of Adverse Events (AE's)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Secondary Outcome Measures
Proportion of Subjects Achieving Renal Response From Baseline to 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
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
Change in Systolic Blood Pressure From Baseline to Day 85
Change in Diastolic Blood Pressure From Baseline to Day 85
Change in Temperature From Baseline to Day 85
Change in Weight From Baseline to Day 85
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02384317
Brief Title
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
Official Title
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
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2015 (Actual)
Primary Completion Date
September 13, 2015 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ChemoCentryx
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunoglobulin A Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCX168 (Avacopan)
Arm Type
Experimental
Arm Description
CCX168 (Avacopan) plus stable dose of RAAS blocker
Intervention Type
Drug
Intervention Name(s)
CCX168
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period
Description
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
Time Frame
Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)
Title
Number of Participants With AE's
Description
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Time Frame
Day 0 - Day 169 (throughout the trial)
Title
Severity of Adverse Events (AE's)
Description
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Time Frame
Day 0 - Day 169 (throughout the trial)
Secondary Outcome Measure Information:
Title
Proportion of Subjects Achieving Renal Response From Baseline to Day 85
Description
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.
Time Frame
Baseline and Day 85
Title
Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85
Description
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.
Time Frame
Baseline and Day 85
Title
Change From Baseline to Day 85 in Vital Signs
Time Frame
Baseline to day 85
Title
Change in Systolic Blood Pressure From Baseline to Day 85
Time Frame
Baseline to day 85
Title
Change in Diastolic Blood Pressure From Baseline to Day 85
Time Frame
Baseline to day 85
Title
Change in Temperature From Baseline to Day 85
Time Frame
Baseline to day 85
Title
Change in Weight From Baseline to Day 85
Time Frame
Baseline to day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Palo Alto
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Reno
State/Province
Nevada
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
We'll reach out to this number within 24 hrs