Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease (NCT NCT06350123)
NCT ID: NCT06350123
Last Updated: 2026-06-26
Results Overview
Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on Urine Albumin-to-Creatinine Ratio (UACR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
324 participants
Primary outcome timeframe
Baseline (Day 1) until Week 12 (Day 85)
Results posted on
2026-06-26
Participant Flow
This study was conducted from 01 May 2024 to 09 May 2025. Recruitment period was from 01 May 2024 to 16 December 2024 when last subject was randomized.
Participants who met all the eligibility criteria were enrolled in the study. All study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Balci 15 mg/ Dapa 10 mg
1 capsule balcinrenone 15 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Balci 40 mg/ Dapa 10 mg
1 capsule balcinrenone 40 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Dapagliflozin 10 mg
Dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
110
|
106
|
|
Overall Study
COMPLETED
|
105
|
107
|
102
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
4
|
Reasons for withdrawal
| Measure |
Balci 15 mg/ Dapa 10 mg
1 capsule balcinrenone 15 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Balci 40 mg/ Dapa 10 mg
1 capsule balcinrenone 40 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Dapagliflozin 10 mg
Dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Balcinrenone/Dapagliflozin 15 mg/10 mg
n=108 Participants
1 capsule balcinrenone 15 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Balcinrenone/Dapagliflozin 40 mg/10 mg
n=110 Participants
1 capsule balcinrenone 40 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Dapagliflozin 10 mg
n=106 Participants
Dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.7 Years
STANDARD_DEVIATION 12.4 • n=20 Participants
|
65.2 Years
STANDARD_DEVIATION 12.3 • n=20 Participants
|
63.9 Years
STANDARD_DEVIATION 12.5 • n=40 Participants
|
64.6 Years
STANDARD_DEVIATION 12.4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
110 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=20 Participants
|
71 Participants
n=20 Participants
|
72 Participants
n=40 Participants
|
214 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
103 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
23 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=20 Participants
|
58 Participants
n=20 Participants
|
65 Participants
n=40 Participants
|
183 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
11 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) until Week 12 (Day 85)Population: Participants included in the primary analysis had a baseline Urine Albumin-to-Creatinine Ratio (UACR) assessment and at least one post-baseline UACR assessment.
Evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on Urine Albumin-to-Creatinine Ratio (UACR).
Outcome measures
| Measure |
Balcinrenone/Dapagliflozin 40 mg/10 mg
n=99 Participants
1 capsule balcinrenone 40 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Dapagliflozin 10 mg
n=103 Participants
Dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Balcinrenone/Dapagliflozin 15 mg/10 mg
n=102 Participants
1 capsule balcinrenone 15 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
|---|---|---|---|
|
Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12
|
0.66 mg/g
Interval 0.59 to 0.73
|
0.98 mg/g
Interval 0.88 to 1.09
|
0.76 mg/g
Interval 0.68 to 0.84
|
Adverse Events
Balcinrenone/Dapagliflozin 15 mg/10 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Balcinrenone/Dapagliflozin 40 mg/10 mg
Serious events: 8 serious events
Other events: 10 other events
Deaths: 0 deaths
Dapagliflozin 10 mg
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Balcinrenone/Dapagliflozin 15 mg/10 mg
n=108 participants at risk
1 capsule balcinrenone 15 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Balcinrenone/Dapagliflozin 40 mg/10 mg
n=110 participants at risk
1 capsule balcinrenone 40 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Dapagliflozin 10 mg
n=106 participants at risk
Dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 2 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.93%
1/108 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
General disorders
Chest pain
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/110 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.94%
1/106 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/108 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.91%
1/110 • Number of events 1 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
0.00%
0/106 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
Other adverse events
| Measure |
Balcinrenone/Dapagliflozin 15 mg/10 mg
n=108 participants at risk
1 capsule balcinrenone 15 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Balcinrenone/Dapagliflozin 40 mg/10 mg
n=110 participants at risk
1 capsule balcinrenone 40 mg and dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
Dapagliflozin 10 mg
n=106 participants at risk
Dapagliflozin 10 mg (once daily) + 1 tablet placebo (once daily)
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.9%
2/108 • Number of events 2 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
3.6%
4/110 • Number of events 4 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
6.6%
7/106 • Number of events 8 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.5%
7/108 • Number of events 7 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
6.4%
7/110 • Number of events 8 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
3.8%
4/106 • Number of events 5 • From screening (Day -21) until Day 113 day, up to 134 days.
Safety set included all participants who were randomized and received any study intervention. All AEs that were reported with an onset date and time, or worsening, on or after date and time of first dose of IP up to and including 28 days after last dose of IP were included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB.
- Publication restrictions are in place
Restriction type: OTHER