Trial Outcomes & Findings for Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy (NCT NCT05834738)
NCT ID: NCT05834738
Last Updated: 2026-07-20
Results Overview
Change in proteinuria from Baseline to Week 12 across both periods between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
From Baseline to Week 12
Results posted on
2026-07-20
Participant Flow
The screening period was up to 6 weeks, during which participants had to meet all eligibility criteria to continue in the study. If a participant who was not on a stable dose of SGLT2i met all screening eligibility criteria, they entered the 8-week Run-In Period.
Participant milestones
| Measure |
Sequence Atrasentan/Placebo
Once daily oral administration of atrasentan 0.75 mg for 12 weeks (Period 1), followed by a 12-week washout and once-daily oral administration of placebo for 24 weeks (Period 2).
|
Sequence Placebo/Atrasentan
Once daily oral administration of placebo for 12 weeks (Period 1) followed by a 12-week washout and once daily oral administration of atrasentan 0.75 mg for 24 weeks (Period 2)
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
Completed treatment period 1
|
27
|
27
|
|
Overall Study
Completed washout period
|
27
|
27
|
|
Overall Study
Completed treatment period 2
|
26
|
26
|
|
Overall Study
Intention-to-Treat (ITT) Analysis Set
|
27
|
27
|
|
Overall Study
Safety Analysis Set
|
27
|
27
|
|
Overall Study
Pharmacokinetic Analysis Set
|
26
|
27
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence Atrasentan/Placebo
Once daily oral administration of atrasentan 0.75 mg for 12 weeks (Period 1), followed by a 12-week washout and once-daily oral administration of placebo for 24 weeks (Period 2).
|
Sequence Placebo/Atrasentan
Once daily oral administration of placebo for 12 weeks (Period 1) followed by a 12-week washout and once daily oral administration of atrasentan 0.75 mg for 24 weeks (Period 2)
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
Baseline characteristics by cohort
| Measure |
Sequence Atrasentan/Placebo
n=27 Participants
Once daily oral administration of atrasentan 0.75 mg for 12 weeks (Period 1), followed by a 12-week washout and once-daily oral administration of placebo for 24 weeks (Period 2).
|
Sequence Placebo/Atrasentan
n=27 Participants
Once daily oral administration of placebo for 12 weeks (Period 1) followed by a 12-week washout and once daily oral administration of atrasentan 0.75 mg for 24 weeks (Period 2)
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 11.43 • n=20 Participants
|
43.2 years
STANDARD_DEVIATION 10.66 • n=20 Participants
|
47.7 years
STANDARD_DEVIATION 11.85 • n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 12Population: Intention-to-Treat (ITT) Analysis Set consisted of all participants randomly assigned to a treatment sequence.
Change in proteinuria from Baseline to Week 12 across both periods between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
Outcome measures
| Measure |
Placebo Period 1
n=54 Participants
Participants who received placebo in Period 1
|
Placebo Period 2
Participants who received placebo in Period 2
|
Atrasentan Period 2
Participants who received atrasentan in Period 2
|
Atrasentan Period 1
n=54 Participants
Participants who received atrasentan in Period 1
|
|---|---|---|---|---|
|
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 12
|
-7.2 percentage change in UPCR
Interval -17.7 to 4.7
|
—
|
—
|
-30.7 percentage change in UPCR
Interval -38.5 to -21.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 24 of Treatment Period 2Population: Participants in the ITT with an available value for the outcome measure in treatment Period 2. Intention-to-Treat (ITT) Analysis Set consisted of all participants randomly assigned to a treatment sequence.
Change in proteinuria from Baseline to Week 24 in Treatment Period 2 between atrasentan versus placebo. Proteinuria was assessed using the urine protein to creatinine ratio (UPCR) measured from a 24-hour urine collection.
Outcome measures
| Measure |
Placebo Period 1
n=27 Participants
Participants who received placebo in Period 1
|
Placebo Period 2
Participants who received placebo in Period 2
|
Atrasentan Period 2
Participants who received atrasentan in Period 2
|
Atrasentan Period 1
n=27 Participants
Participants who received atrasentan in Period 1
|
|---|---|---|---|---|
|
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 24 in Treatment Period 2.
|
-0.9 percentage change in UPCR
Interval -20.6 to 23.7
|
—
|
—
|
-27.0 percentage change in UPCR
Interval -41.0 to -9.8
|
SECONDARY outcome
Timeframe: From first dose of study treatment until end of study, up to 60 weeksPopulation: The Safety analysis set consisted of all participants randomly assigned to a treatment sequence who took at least one dose of study drug.
Number of Subjects With Treatment-Emergent Adverse Events (TEAE) and Treatment-Emergent Adverse Events of Special Interest (TEAESI). Severity assessment of AEs was based on CTCAE (Common Terminology Criteria for Adverse Events).
Outcome measures
| Measure |
Placebo Period 1
n=27 Participants
Participants who received placebo in Period 1
|
Placebo Period 2
n=27 Participants
Participants who received placebo in Period 2
|
Atrasentan Period 2
n=27 Participants
Participants who received atrasentan in Period 2
|
Atrasentan Period 1
n=27 Participants
Participants who received atrasentan in Period 1
|
|---|---|---|---|---|
|
Number of Subjects With TEAE and TEAESI
Adverse events (AEs)
|
17 Participants
|
17 Participants
|
16 Participants
|
19 Participants
|
|
Number of Subjects With TEAE and TEAESI
Treatment-related AEs
|
4 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Number of Subjects With TEAE and TEAESI
Any Moderate or Severe AEs
|
7 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects With TEAE and TEAESI
Treatment-related Moderate or Severe AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With TEAE and TEAESI
Severe AEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With TEAE and TEAESI
Treatment-related Severe AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With TEAE and TEAESI
SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With TEAE and TEAESI
Treatment-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With TEAE and TEAESI
Adverse events of special interest
|
2 Participants
|
6 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With TEAE and TEAESI
Treatment-related AEs of special interest
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Number of Subjects With TEAE and TEAESI
Serious adverse events of special interest
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment Period 1: Pre-dose on Weeks 2, 6 and 12; Treatment Period 2: Pre-dose on Weeks 2, 6, 12 and 24Population: The Pharmacokinetic (PK) Analysis Set consisted of all participants in the Safety Analysis Set who have at least one non-missing concentration value reported by the bioanalytical laboratory. Only participants with non-missing atrasentan plasma concentration value were included.
Blood samples were collected for the measurement of plasma concentrations of atrasentan.
Outcome measures
| Measure |
Placebo Period 1
n=27 Participants
Participants who received placebo in Period 1
|
Placebo Period 2
Participants who received placebo in Period 2
|
Atrasentan Period 2
Participants who received atrasentan in Period 2
|
Atrasentan Period 1
n=26 Participants
Participants who received atrasentan in Period 1
|
|---|---|---|---|---|
|
Plasma Concentration of Atrasentan
Week 2 - Predose
|
1.13 ng/mL
Interval 0.579 to 1.53
|
—
|
—
|
1.07 ng/mL
Interval 0.866 to 1.81
|
|
Plasma Concentration of Atrasentan
Week 6 - Predose
|
1.26 ng/mL
Interval 0.855 to 1.47
|
—
|
—
|
1.41 ng/mL
Interval 1.08 to 2.39
|
|
Plasma Concentration of Atrasentan
Week 12 - Predose
|
1.17 ng/mL
Interval 0.633 to 1.61
|
—
|
—
|
1.28 ng/mL
Interval 0.846 to 2.19
|
|
Plasma Concentration of Atrasentan
Week 24 - Predose
|
1.06 ng/mL
Interval 0.547 to 1.38
|
—
|
—
|
—
|
Adverse Events
Run-in Total
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment Period: Atrasentan
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment Period 1: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment Period 1 Total
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Washout Period: Atrasentan
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Washout Period: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Washout Period Total
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment Period 2: Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Treatment Period 2: Atrasentan
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Period 2 Total
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Follow-up Period: Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up Period: Atrasentan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Follow-up Period: Total
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Run-in Total
n=54 participants at risk
Participants who have not been on a stable dose of SGLT2i prior to study entry were required to complete the 8-week run-in period
|
Treatment Period: Atrasentan
n=27 participants at risk
Once daily oral administration of 0.75 mg atrasentan for 12 weeks (Period 1)
|
Treatment Period 1: Placebo
n=27 participants at risk
Once daily oral administration of placebo for 12 weeks (Period 1)
|
Treatment Period 1 Total
n=54 participants at risk
Once daily oral administration of atrasentan or placebo for 12 weeks (Period 1)
|
Washout Period: Atrasentan
n=27 participants at risk
12-week washout period after 12 weeks of treatment with atrasentan in Period 1
|
Washout Period: Placebo
n=27 participants at risk
12-week washout period after 12 weeks of placebo in Period 1
|
Washout Period Total
n=54 participants at risk
All participants entered a 12-week washout period before entering Treatment Period 2.
|
Treatment Period 2: Placebo
n=27 participants at risk
Once daily oral administration of placebo for 24 weeks (Period 2)
|
Treatment Period 2: Atrasentan
n=27 participants at risk
Once daily oral administration of 0.75 mg atrasentan for 24 weeks (Period 2)
|
Treatment Period 2 Total
n=54 participants at risk
Once daily oral administration of atrasentan or placebo for 24 weeks (Period 2)
|
Follow-up Period: Placebo
n=27 participants at risk
4-week safety follow-up period after 24 weeks of placebo in Period 2
|
Follow-up Period: Atrasentan
n=27 participants at risk
4-week safety follow-up period after 24 weeks of atrasentan treatment in Period 2
|
Follow-up Period: Total
n=54 participants at risk
4-week safety follow-up period after 24 weeks of atrasentan or placebo in Period 2
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
Other adverse events
| Measure |
Run-in Total
n=54 participants at risk
Participants who have not been on a stable dose of SGLT2i prior to study entry were required to complete the 8-week run-in period
|
Treatment Period: Atrasentan
n=27 participants at risk
Once daily oral administration of 0.75 mg atrasentan for 12 weeks (Period 1)
|
Treatment Period 1: Placebo
n=27 participants at risk
Once daily oral administration of placebo for 12 weeks (Period 1)
|
Treatment Period 1 Total
n=54 participants at risk
Once daily oral administration of atrasentan or placebo for 12 weeks (Period 1)
|
Washout Period: Atrasentan
n=27 participants at risk
12-week washout period after 12 weeks of treatment with atrasentan in Period 1
|
Washout Period: Placebo
n=27 participants at risk
12-week washout period after 12 weeks of placebo in Period 1
|
Washout Period Total
n=54 participants at risk
All participants entered a 12-week washout period before entering Treatment Period 2.
|
Treatment Period 2: Placebo
n=27 participants at risk
Once daily oral administration of placebo for 24 weeks (Period 2)
|
Treatment Period 2: Atrasentan
n=27 participants at risk
Once daily oral administration of 0.75 mg atrasentan for 24 weeks (Period 2)
|
Treatment Period 2 Total
n=54 participants at risk
Once daily oral administration of atrasentan or placebo for 24 weeks (Period 2)
|
Follow-up Period: Placebo
n=27 participants at risk
4-week safety follow-up period after 24 weeks of placebo in Period 2
|
Follow-up Period: Atrasentan
n=27 participants at risk
4-week safety follow-up period after 24 weeks of atrasentan treatment in Period 2
|
Follow-up Period: Total
n=54 participants at risk
4-week safety follow-up period after 24 weeks of atrasentan or placebo in Period 2
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
5.6%
3/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
5.6%
3/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
14.8%
4/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
4/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
11.1%
3/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
4/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
11.1%
3/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
9.3%
5/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
11.1%
3/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
5.6%
3/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
11.1%
3/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
4/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Nervous system disorders
Headache
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
4/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
2/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
5.6%
3/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
2/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
1.9%
1/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
11.1%
3/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
3.7%
1/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
7.4%
4/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/27 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
0.00%
0/54 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days, up to a maximum duration of 60 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER