Trial Outcomes & Findings for Controlled Trial Evaluating Avacopan in C3 Glomerulopathy (NCT NCT03301467)
NCT ID: NCT03301467
Last Updated: 2025-03-13
Results Overview
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
COMPLETED
PHASE2
57 participants
Week 26
2025-03-13
Participant Flow
Participant milestones
| Measure |
Placebo Group
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 patients missed baseline Urinary MCP-1 data.
Baseline characteristics by cohort
| Measure |
Placebo Group
n=29 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=28 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 17.53 • n=29 Participants
|
32.2 years
STANDARD_DEVIATION 15.03 • n=28 Participants
|
34.7 years
STANDARD_DEVIATION 16.39 • n=57 Participants
|
|
Age, Customized
12-17 years
|
2 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
2 Participants
n=57 Participants
|
|
Age, Customized
18-50 years
|
20 Participants
n=29 Participants
|
23 Participants
n=28 Participants
|
43 Participants
n=57 Participants
|
|
Age, Customized
51-65 years
|
4 Participants
n=29 Participants
|
4 Participants
n=28 Participants
|
8 Participants
n=57 Participants
|
|
Age, Customized
>65 years
|
3 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
4 Participants
n=57 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=29 Participants
|
9 Participants
n=28 Participants
|
22 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=29 Participants
|
19 Participants
n=28 Participants
|
35 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=29 Participants
|
2 Participants
n=28 Participants
|
6 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=29 Participants
|
26 Participants
n=28 Participants
|
51 Participants
n=57 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=29 Participants
|
2 Participants
n=28 Participants
|
5 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=57 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=29 Participants
|
24 Participants
n=28 Participants
|
49 Participants
n=57 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=57 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=29 Participants
|
3 participants
n=28 Participants
|
5 participants
n=57 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=29 Participants
|
1 participants
n=28 Participants
|
6 participants
n=57 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=29 Participants
|
2 participants
n=28 Participants
|
3 participants
n=57 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=29 Participants
|
11 participants
n=28 Participants
|
21 participants
n=57 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=29 Participants
|
3 participants
n=28 Participants
|
6 participants
n=57 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=29 Participants
|
1 participants
n=28 Participants
|
2 participants
n=57 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=29 Participants
|
0 participants
n=28 Participants
|
1 participants
n=57 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=29 Participants
|
2 participants
n=28 Participants
|
4 participants
n=57 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=29 Participants
|
1 participants
n=28 Participants
|
3 participants
n=57 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=29 Participants
|
4 participants
n=28 Participants
|
6 participants
n=57 Participants
|
|
Geographic Region
North America
|
12 Participants
n=29 Participants
|
14 Participants
n=28 Participants
|
26 Participants
n=57 Participants
|
|
Geographic Region
Rest of World
|
17 Participants
n=29 Participants
|
14 Participants
n=28 Participants
|
31 Participants
n=57 Participants
|
|
Age at Diagnosis of C3G
|
33.3 years
STANDARD_DEVIATION 17.95 • n=29 Participants
|
28.2 years
STANDARD_DEVIATION 17.08 • n=28 Participants
|
30.8 years
STANDARD_DEVIATION 17.56 • n=57 Participants
|
|
C3GN or DDD
C3GN
|
25 Participants
n=29 Participants
|
23 Participants
n=28 Participants
|
48 Participants
n=57 Participants
|
|
C3GN or DDD
DDD
|
4 Participants
n=29 Participants
|
4 Participants
n=28 Participants
|
8 Participants
n=57 Participants
|
|
C3GN or DDD
Missing
|
0 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=57 Participants
|
|
History of Kidney Transplant
Yes
|
2 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
3 Participants
n=57 Participants
|
|
History of Kidney Transplant
No
|
27 Participants
n=29 Participants
|
26 Participants
n=28 Participants
|
53 Participants
n=57 Participants
|
|
History of Kidney Transplant
Missing
|
0 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=57 Participants
|
|
C5b-9 Stratum
> 244 ng/mL
|
22 Participants
n=29 Participants
|
21 Participants
n=28 Participants
|
43 Participants
n=57 Participants
|
|
C5b-9 Stratum
<= 244 ng/mL
|
7 Participants
n=29 Participants
|
7 Participants
n=28 Participants
|
14 Participants
n=57 Participants
|
|
Duration of C3G
|
46.7 months
STANDARD_DEVIATION 43.78 • n=29 Participants
|
48.2 months
STANDARD_DEVIATION 46.38 • n=28 Participants
|
47.4 months
STANDARD_DEVIATION 44.68 • n=57 Participants
|
|
eGFR
|
72.34 mL/min/1.73m²
STANDARD_DEVIATION 43.509 • n=29 Participants
|
79.29 mL/min/1.73m²
STANDARD_DEVIATION 39.751 • n=28 Participants
|
75.75 mL/min/1.73m²
STANDARD_DEVIATION 41.480 • n=57 Participants
|
|
UPCR
|
2.80 g/g
STANDARD_DEVIATION 2.435 • n=29 Participants
|
4.11 g/g
STANDARD_DEVIATION 3.380 • n=28 Participants
|
3.44 g/g
STANDARD_DEVIATION 2.985 • n=57 Participants
|
|
UPCR (g/g)
> 1 g/g
|
21 Participants
n=29 Participants
|
22 Participants
n=28 Participants
|
43 Participants
n=57 Participants
|
|
UPCR (g/g)
<= 1 g/g
|
8 Participants
n=29 Participants
|
6 Participants
n=28 Participants
|
14 Participants
n=57 Participants
|
|
Urinary MCP-1:Creatinine Ratio
|
750.29 pg/mg Creatinine
STANDARD_DEVIATION 492.542 • n=28 Participants • 2 patients missed baseline Urinary MCP-1 data.
|
1215.88 pg/mg Creatinine
STANDARD_DEVIATION 1303.359 • n=27 Participants • 2 patients missed baseline Urinary MCP-1 data.
|
978.85 pg/mg Creatinine
STANDARD_DEVIATION 997.191 • n=55 Participants • 2 patients missed baseline Urinary MCP-1 data.
|
|
Body Weight
|
72.65 kilogram(s)
STANDARD_DEVIATION 12.631 • n=29 Participants
|
78.33 kilogram(s)
STANDARD_DEVIATION 19.229 • n=28 Participants
|
75.44 kilogram(s)
STANDARD_DEVIATION 16.317 • n=57 Participants
|
|
Height
|
171.41 centimeter(s)
STANDARD_DEVIATION 8.773 • n=29 Participants
|
173.82 centimeter(s)
STANDARD_DEVIATION 10.805 • n=28 Participants
|
172.60 centimeter(s)
STANDARD_DEVIATION 9.810 • n=57 Participants
|
|
BMI
|
24.65 kilogram(s)/square meter
STANDARD_DEVIATION 3.410 • n=29 Participants
|
26.05 kilogram(s)/square meter
STANDARD_DEVIATION 6.375 • n=28 Participants
|
25.34 kilogram(s)/square meter
STANDARD_DEVIATION 5.090 • n=57 Participants
|
|
EQ-5D-5L Index Score
|
0.88 units on a scale
STANDARD_DEVIATION 0.145 • n=29 Participants
|
0.87 units on a scale
STANDARD_DEVIATION 0.116 • n=28 Participants
|
0.88 units on a scale
STANDARD_DEVIATION 0.130 • n=57 Participants
|
|
EQ-5D-5L VAS Score
|
78.83 units on a scale
STANDARD_DEVIATION 20.604 • n=29 Participants
|
73.61 units on a scale
STANDARD_DEVIATION 19.070 • n=28 Participants
|
76.26 units on a scale
STANDARD_DEVIATION 19.862 • n=57 Participants
|
|
Viral Test Results HIV-1/2 Antibody
Reactive
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Viral Test Results HIV-1/2 Antibody
Non-reactive
|
29 Participants
n=29 Participants
|
28 Participants
n=28 Participants
|
57 Participants
n=57 Participants
|
|
Viral Test Results - Hepatitis B Virus Surface Antigen
Reactive
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Viral Test Results - Hepatitis B Virus Surface Antigen
Non-reactive
|
29 Participants
n=29 Participants
|
28 Participants
n=28 Participants
|
57 Participants
n=57 Participants
|
|
Viral Test Results - Hepatitis C Virus Antibody
Reactive
|
0 Participants
n=29 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=57 Participants
|
|
Viral Test Results - Hepatitis C Virus Antibody
Non-reactive
|
29 Participants
n=29 Participants
|
27 Participants
n=28 Participants
|
56 Participants
n=57 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
Outcome measures
| Measure |
Placebo Group
n=21 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=19 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9
|
-0.9 score on a scale
Interval -2.2 to 0.4
|
-1.0 score on a scale
Interval -2.3 to 0.4
|
PRIMARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy \* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.
Outcome measures
| Measure |
Placebo Group
n=26 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=26 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata
|
26.20 Percentage change
Standard Error 47.302
|
-5.77 Percentage change
Standard Error 5.904
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
Outcome measures
| Measure |
Placebo Group
n=20 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=18 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9
Responder
|
4 Participants
|
2 Participants
|
|
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9
Non-Responder
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported. The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement. C3G=C3 glomerulopathy
Outcome measures
| Measure |
Placebo Group
n=25 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=25 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata
Responder
|
7 Participants
|
4 Participants
|
|
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 Strata
Non-Responder
|
18 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement. C3G=C3 glomerulopathy
Outcome measures
| Measure |
Placebo Group
n=21 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=19 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9
|
1.5 score on a scale
Interval 0.9 to 2.2
|
1.1 score on a scale
Interval 0.3 to 1.8
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement. C3G=C3 glomerulopathy
Outcome measures
| Measure |
Placebo Group
n=26 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=26 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata
|
1.6 score on a scale
Interval 1.1 to 2.2
|
0.8 score on a scale
Interval 0.2 to 1.4
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
Outcome measures
| Measure |
Placebo Group
n=20 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=18 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9
|
-4.73 Percentage change
Interval -12.29 to 2.83
|
6.11 Percentage change
Interval -1.86 to 14.08
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
Outcome measures
| Measure |
Placebo Group
n=25 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=25 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata
|
-5.88 Percentage change
Interval -12.32 to 0.56
|
4.79 Percentage change
Interval -1.66 to 11.23
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
Outcome measures
| Measure |
Placebo Group
n=20 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=18 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9
|
-3.57 mL/min/1.73m^2
Interval -8.43 to 1.29
|
0.44 mL/min/1.73m^2
Interval -4.69 to 5.56
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
Outcome measures
| Measure |
Placebo Group
n=25 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=25 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata
|
-3.35 mL/min/1.73m^2
Interval -7.56 to 0.85
|
0.47 mL/min/1.73m^2
Interval -3.75 to 4.68
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
Outcome measures
| Measure |
Placebo Group
n=20 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=18 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9
|
-14 Percentage change
Interval -34.0 to 12.0
|
-16 Percentage change
Interval -36.0 to 12.0
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
Outcome measures
| Measure |
Placebo Group
n=25 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=24 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 Strata
|
-14 Percentage change
Interval -33.0 to 10.0
|
-26 Percentage change
Interval -42.0 to -6.0
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
Outcome measures
| Measure |
Placebo Group
n=19 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=17 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Subjects With Elevated C5b-9
|
1 Percentage change
Interval -18.0 to 25.0
|
-23 Percentage change
Interval -39.0 to -4.0
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Percent change from baseline over 26 weeks in urinary MCP-1: creatinine ratio - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. LSM=Least Squares Mean; MCP-1=Monocyte Chemoattractant Protein-1
Outcome measures
| Measure |
Placebo Group
n=24 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=23 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Percent Change From Baseline Over 26 Weeks in Urinary MCP-1 - Combined C5b-9 Strata
|
1 Percentage change
Interval -17.0 to 23.0
|
-12 Percentage change
Interval -28.0 to 7.0
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
Outcome measures
| Measure |
Placebo Group
n=20 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=18 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9
EQ-5D-5L Index Score
|
0.0220 score on a scale
Interval -0.0206 to 0.0647
|
-0.0202 score on a scale
Interval -0.0653 to 0.0249
|
|
Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Subjects With Elevated C5b-9
EQ-5D-5L VAS Score
|
-3.5 score on a scale
Interval -7.8 to 0.8
|
-1.9 score on a scale
Interval -6.4 to 2.7
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Change from baseline over 26 weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given can be converted into an Index Score ranging from 0 for death to 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst imaginable health) to 100 (the best imaginable health).
Outcome measures
| Measure |
Placebo Group
n=25 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=25 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata
EQ-5D-5L VAS Score
|
0.1 score on a scale
Interval -3.9 to 4.2
|
-1.9 score on a scale
Interval -6.0 to 2.2
|
|
Change From Baseline Over 26 Weeks in EQ-5D-5L Health Scale VAS and Index Score - Combined C5b-9 Strata
EQ-5D-5L Index Score
|
0.0060 score on a scale
Interval -0.0334 to 0.0454
|
-0.0138 score on a scale
Interval -0.0533 to 0.0256
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Change from baseline over 26 weeks in SF-36 v2 - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population. SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
Outcome measures
| Measure |
Placebo Group
n=21 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=19 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Physical Functioning
|
2.8518 score on a scale
Interval -3.2409 to 8.9446
|
3.2197 score on a scale
Interval -3.3108 to 9.7502
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Role-Physical
|
-4.2592 score on a scale
Interval -11.5984 to 3.0801
|
3.5162 score on a scale
Interval -4.2634 to 11.2958
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Bodily Pain
|
3.6 score on a scale
Interval -4.2 to 11.4
|
-3.5 score on a scale
Interval -12.0 to 4.9
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: General Health Perceptions
|
-0.9 score on a scale
Interval -7.0 to 5.2
|
1.6 score on a scale
Interval -4.8 to 8.0
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Vitality
|
-2.472 score on a scale
Interval -8.906 to 3.963
|
3.898 score on a scale
Interval -2.978 to 10.774
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Social Functioning
|
4.58 score on a scale
Interval -2.3 to 11.47
|
0.34 score on a scale
Interval -7.2 to 7.88
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Role-Emotional
|
0.6859 score on a scale
Interval -6.8507 to 8.2225
|
3.2461 score on a scale
Interval -4.6899 to 11.1821
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Mental Health
|
2.423 score on a scale
Interval -3.684 to 8.53
|
2.730 score on a scale
Interval -3.791 to 9.251
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Physical Component
|
-0.3257 score on a scale
Interval -2.609 to 1.9576
|
0.0762 score on a scale
Interval -2.4423 to 2.5947
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Subjects With Elevated C5b-9
SF-36v2: Mental Component
|
0.7556 score on a scale
Interval -2.356 to 3.8672
|
0.7608 score on a scale
Interval -2.6341 to 4.1558
|
SECONDARY outcome
Timeframe: Week 26Population: Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported. ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population.
Change from baseline over 26 weeks in SF-36 v2 - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population. SF-36v2: Medical Outcomes Survey Short Form-36 version 2. SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
Outcome measures
| Measure |
Placebo Group
n=26 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=26 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Physical Functioning
|
2.9619 score on a scale
Interval -2.715 to 8.6389
|
4.6532 score on a scale
Interval -1.1123 to 10.4187
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Role-Physical
|
-2.4712 score on a scale
Interval -9.6179 to 4.6755
|
1.2077 score on a scale
Interval -5.9734 to 8.3887
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Bodily Pain
|
1.5 score on a scale
Interval -5.7 to 8.7
|
-2.0 score on a scale
Interval -9.3 to 5.4
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: General Health Perceptions
|
-1.0 score on a scale
Interval -6.6 to 4.6
|
0.7 score on a scale
Interval -4.9 to 6.2
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Vitality
|
-0.468 score on a scale
Interval -6.283 to 5.348
|
4.085 score on a scale
Interval -1.782 to 9.952
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Social Functioning
|
4.66 score on a scale
Interval -1.41 to 10.73
|
1.55 score on a scale
Interval -4.66 to 7.76
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Role-Emotional
|
4.3024 score on a scale
Interval -3.3147 to 11.9195
|
7.8375 score on a scale
Interval 0.2129 to 15.462
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Mental Health
|
1.503 score on a scale
Interval -3.911 to 6.917
|
3.914 score on a scale
Interval -1.543 to 9.37
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Physical Component
|
-0.3578 score on a scale
Interval -2.5452 to 1.8296
|
-0.5096 score on a scale
Interval -2.768 to 1.7489
|
|
Change From Baseline Over 26 Weeks in SF-36 v2 - Combined C5b-9 Strata
SF-36v2: Mental Component
|
1.3591 score on a scale
Interval -1.797 to 4.5153
|
2.3874 score on a scale
Interval -0.8529 to 5.6277
|
SECONDARY outcome
Timeframe: From day 1 throughout the study period (day 182/week 26)Population: Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.
Number of Subjects with Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
Outcome measures
| Measure |
Placebo Group
n=29 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=28 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of subjects with at least one TEAE
|
24 participants
|
25 participants
|
|
Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of subjects with SAEs
|
3 participants
|
3 participants
|
|
Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of subjects with TEAEs possibly related to Study Medication
|
11 participants
|
10 participants
|
|
Number of Subjects With Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of subjects with TEAEs leading to discontinuation
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: From day 1 throughout the study period (day 182/week 26)Population: Safety Population: The safety population included all subjects who were randomized and had received at least one dose of study drug.
Number of Treatment-emergent SAEs, AEs, relatedness to study medication and Withdrawals Due to AEs AEs=Adverse events SAEs=Serious adverse events TEAE=Treatment-emergent adverse events 'Possibly related' refers to the Investigators' causality assessment
Outcome measures
| Measure |
Placebo Group
n=29 Participants
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
|
Avacopan Group
n=28 Participants
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
|
|---|---|---|
|
Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of TEAEs
|
107 Adverse events
|
149 Adverse events
|
|
Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of SAEs
|
4 Adverse events
|
6 Adverse events
|
|
Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of TEAEs possibly related to Study Medication
|
24 Adverse events
|
38 Adverse events
|
|
Number of Treatment-emergent SAEs, AEs, Relatedness to Study Medication and Withdrawals Due to AEs
Number of TEAEs leading to discontinuation
|
2 Adverse events
|
2 Adverse events
|
Adverse Events
Placebo Group
Avacopan Group
Serious adverse events
| Measure |
Placebo Group
n=29 participants at risk
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
The safety population included all subjects who were randomized and had received at least one dose of study drug.
|
Avacopan Group
n=28 participants at risk
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
The safety population included all subjects who were randomized and had received at least one dose of study drug.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Pneumonia
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Bacterial parotitis
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Bronchitis
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
Other adverse events
| Measure |
Placebo Group
n=29 participants at risk
Avacopan-matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period
Avacopan-matching placebo: Orally administered
The safety population included all subjects who were randomized and had received at least one dose of study drug.
|
Avacopan Group
n=28 participants at risk
Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
Avacopan: Orally administered
The safety population included all subjects who were randomized and had received at least one dose of study drug.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
17.9%
5/28 • Number of events 6 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
General disorders
Fatigue
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
General disorders
Pyrexia
|
6.9%
2/29 • Number of events 4 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
3/29 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
3/29 • Number of events 4 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
14.3%
4/28 • Number of events 4 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
3/29 • Number of events 4 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
3/29 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Investigations
Blood creatine phosphokinase increased
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 4 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Investigations
Weight decreased
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Investigations
Lipase increased
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Blood and lymphatic system disorders
Anaemia
|
10.3%
3/29 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
3/29 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Nervous system disorders
Headache
|
6.9%
2/29 • Number of events 4 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
17.9%
5/28 • Number of events 5 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Nervous system disorders
Tremor
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
3.6%
1/28 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.4%
1/29 • Number of events 1 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Psychiatric disorders
Depression
|
0.00%
0/29 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
7.1%
2/28 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Vascular disorders
Hypertension
|
10.3%
3/29 • Number of events 3 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
10.7%
3/28 • Number of events 4 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
|
Vascular disorders
Orthostatic hypotension
|
6.9%
2/29 • Number of events 2 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
0.00%
0/28 • From day 1 throughout the study period (day 182/week 26)
An adverse event is considered treatment-emergent if the start date/time of the event is on or after the date/time of first study drug treatment up to the final observation in the double-blind treatment period (week 26).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication. Sponsor may request in writing, and the PI shall agree to, (a) the deletion of any Confidential Information, (b) any reasonable changes requested by Sponsor, or (c) a delay of such proposed submission for an additional period, not to exceed 90 days.
- Publication restrictions are in place
Restriction type: OTHER