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.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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.
Unnamed facility
Palo Alto, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Reno, Nevada, United States
Unnamed facility
Chapel Hill, North Carolina, United States
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
Time frame: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)
Number of Participants With AE's
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Time frame: Day 0 - Day 169 (throughout the trial)
Severity of Adverse Events (AE's)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Time frame: Day 0 - Day 169 (throughout the trial)
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.
Time frame: Baseline and Day 85
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.
Time frame: Baseline and Day 85
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
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Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Stockholm, Sweden
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