Diabetic Nephropathies
Conditions
Brief summary
To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.
Interventions
DRUGPlacebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country * Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active. * Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria * are on oral antidiabetics and / or insulin, * have a documented fasting glucose \>/= 7.0 mmol/L in the medical history, * have a 2 hour plasma glucose \>/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or * have a glycated hemoglobin (HbA1c) \>/=6.5% \[National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)\] in the medical history or at the run-in visit * Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria: * Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of \>/=300 mg/g ( \>/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or * Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g in (\>/=3.4mg/mmol but \<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m² * Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit * Serum potassium \</= 4.8 mmol/L at both the run-in visit and the screening visit
Exclusion criteria
* Non-diabetic renal disease * Glycated hemoglobin (HbA1c) \>12% at the run-in visit or the screening visit * UACR \>3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit * Hypertension with mean sitting systolic blood pressure (SBP) \>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \>/=110 mmHg at the run-in visit or mean supine SBP \>/=160 mmHg or mean sitting DBP \>/=100 mmHg at the screening visit * Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit * Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic * Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of UACR at Day 90 to UACR at Baseline | Baseline and Day 90±2 | Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 90 in Serum Potassium | Baseline and Day 90±2 | — |
| Change From Baseline to Day 90 in eGFR | Baseline and Day 90±2 | An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. |
| Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | Baseline and Day 90±2 | The Kidney Disease QOL \[KDQOL\]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). Effects of Kidney disease subscore was analyzed. |
| Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | Baseline and Day 90±2 | EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state). |
Countries
Australia, Austria, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Norway, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Taiwan, United States
Participant flow
Recruitment details
The study was conducted at 148 study centers in 23 countries, from 12 June 2013 (first participant, first visit) to 07 August 2014 (last participant, last visit). The randomization was stratified by region (Europe, North America, Asia, others \[Australia, Israel, and South Africa\]), and type of albuminuria at screening (very high or high albuminuria).
Pre-assignment details
Of 1501 participants screened, 823 were randomized at 128 study centers and 678 were screening failures. The reasons were not fulfilled inclusion-/exclusion criteria's (635 participants), withdrawal by participants (37 participants), adverse event (3 participants), physician decision (2 participants), logistical difficulties (1 participant) and lost to follow-up (1 participant).
Participants by arm
| Arm | Count |
|---|---|
| Finerenone (BAY94-8862) (1.25 mg) 1.25 milligram (mg) BAY94-8862 tablet once daily in the morning for 90 days. | 96 |
| Finerenone (BAY94-8862) (2.5 mg) 2.5 mg BAY94-8862 tablet once daily in the morning for 90 days. | 92 |
| Finerenone (BAY94-8862) (5 mg) 5 mg BAY94-8862 tablet once daily in the morning for 90 days. | 100 |
| Finerenone (BAY94-8862) (7.5 mg) 7.5 mg BAY94-8862 tablet once daily in the morning for 90 days. | 97 |
| Finerenone (BAY94-8862) (10 mg) 10 mg BAY94-8862 tablet once daily in the morning for 90 days. | 98 |
| Finerenone (BAY94-8862) (15 mg) 15 mg BAY94-8862 tablet once daily in the morning for 90 days. | 125 |
| Finerenone (BAY94-8862) (20 mg) 20 mg BAY94-8862 tablet once daily in the morning for 90 days | 119 |
| Placebo Placebo tablet once daily in the morning for 90 days. | 94 |
| Total | 821 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 | 6 | 5 | 2 | 8 | 2 | 3 |
| Overall Study | Logistical difficulties | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Non-compliance | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 1 | 0 | 3 | 2 | 1 | 1 |
| Overall Study | Sponsor decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 2 | 1 | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | Finerenone (BAY94-8862) (15 mg) | Finerenone (BAY94-8862) (20 mg) | Placebo | Total | Finerenone (BAY94-8862) (1.25 mg) | Finerenone (BAY94-8862) (2.5 mg) | Finerenone (BAY94-8862) (5 mg) | Finerenone (BAY94-8862) (7.5 mg) | Finerenone (BAY94-8862) (10 mg) |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 63.95 years STANDARD_DEVIATION 8.34 | 64.70 years STANDARD_DEVIATION 9.26 | 63.26 years STANDARD_DEVIATION 8.68 | 64.21 years STANDARD_DEVIATION 9.15 | 64.91 years STANDARD_DEVIATION 9.57 | 64.86 years STANDARD_DEVIATION 9.09 | 63.31 years STANDARD_DEVIATION 8.79 | 63.73 years STANDARD_DEVIATION 10.04 | 64.94 years STANDARD_DEVIATION 9.62 |
| Baseline eGFR | 67.455 mL/min/1.73m^2 STANDARD_DEVIATION 23.646 | 66.039 mL/min/1.73m^2 STANDARD_DEVIATION 22.205 | 72.213 mL/min/1.73m^2 STANDARD_DEVIATION 20.434 | 67.544 mL/min/1.73m^2 STANDARD_DEVIATION 21.772 | 66.113 mL/min/1.73m^2 STANDARD_DEVIATION 21.923 | 67.425 mL/min/1.73m^2 STANDARD_DEVIATION 20.164 | 67.080 mL/min/1.73m^2 STANDARD_DEVIATION 22.205 | 67.497 mL/min/1.73m^2 STANDARD_DEVIATION 21.917 | 67.042 mL/min/1.73m^2 STANDARD_DEVIATION 20.857 |
| Baseline EQ-5D scores (EQ5D - Visual Analog Scale) | 73.19 Score on a scale STANDARD_DEVIATION 16.11 | 71.36 Score on a scale STANDARD_DEVIATION 17.49 | 70.05 Score on a scale STANDARD_DEVIATION 17.69 | 72.56 Score on a scale STANDARD_DEVIATION 16.42 | 71.76 Score on a scale STANDARD_DEVIATION 16.39 | 72.79 Score on a scale STANDARD_DEVIATION 14.81 | 73.01 Score on a scale STANDARD_DEVIATION 16.21 | 74.49 Score on a scale STANDARD_DEVIATION 15.92 | 73.89 Score on a scale STANDARD_DEVIATION 16.47 |
| Baseline KDQOL-36 domain score (Effects of Kidney Disease) | 90.45 Scores on a scale STANDARD_DEVIATION 14.39 | 89.10 Scores on a scale STANDARD_DEVIATION 17.45 | 81.45 Scores on a scale STANDARD_DEVIATION 20.42 | 90.57 Scores on a scale STANDARD_DEVIATION 13.69 | 90.78 Scores on a scale STANDARD_DEVIATION 10.28 | 92.53 Scores on a scale STANDARD_DEVIATION 9.57 | 91.78 Scores on a scale STANDARD_DEVIATION 12.55 | 92.99 Scores on a scale STANDARD_DEVIATION 11.04 | 88.71 Scores on a scale STANDARD_DEVIATION 16.5 |
| Baseline potassium | 4.288 mmol/L STANDARD_DEVIATION 0.459 | 4.294 mmol/L STANDARD_DEVIATION 0.439 | 4.254 mmol/L STANDARD_DEVIATION 0.479 | 4.297 mmol/L STANDARD_DEVIATION 0.427 | 4.323 mmol/L STANDARD_DEVIATION 0.425 | 4.297 mmol/L STANDARD_DEVIATION 0.426 | 4.314 mmol/L STANDARD_DEVIATION 0.325 | 4.311 mmol/L STANDARD_DEVIATION 0.435 | 4.297 mmol/L STANDARD_DEVIATION 0.42 |
| Baseline UACR | 450.12 g/kg STANDARD_DEVIATION 657.04 | 379.28 g/kg STANDARD_DEVIATION 457.33 | 377.28 g/kg STANDARD_DEVIATION 542.27 | 417.16 g/kg STANDARD_DEVIATION 599.12 | 412.02 g/kg STANDARD_DEVIATION 507.51 | 471.01 g/kg STANDARD_DEVIATION 784.84 | 402.04 g/kg STANDARD_DEVIATION 535.44 | 405.14 g/kg STANDARD_DEVIATION 702.63 | 441.16 g/kg STANDARD_DEVIATION 571.27 |
| Sex: Female, Male Female | 27 Participants | 30 Participants | 25 Participants | 182 Participants | 18 Participants | 14 Participants | 29 Participants | 18 Participants | 21 Participants |
| Sex: Female, Male Male | 98 Participants | 89 Participants | 69 Participants | 639 Participants | 78 Participants | 78 Participants | 71 Participants | 79 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 92 | 0 / 100 | 0 / 97 | 0 / 98 | 1 / 125 | 0 / 119 | 1 / 94 |
| other Total, other adverse events | 14 / 96 | 7 / 92 | 13 / 100 | 11 / 97 | 10 / 98 | 11 / 125 | 12 / 119 | 8 / 94 |
| serious Total, serious adverse events | 5 / 96 | 3 / 92 | 7 / 100 | 8 / 97 | 2 / 98 | 6 / 125 | 4 / 119 | 3 / 94 |
Outcome results
Primary
Ratio of UACR at Day 90 to UACR at Baseline
Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
Time frame: Baseline and Day 90±2
Population: Full analysis set (FAS): included all participants of the SAF who had baseline and at least one post-baseline UACR value.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Finerenone (BAY94-8862) (1.25 mg) | Ratio of UACR at Day 90 to UACR at Baseline | 0.869 Ratio | 90% Confidence Interval 0.772 |
| Finerenone (BAY94-8862) (2.5 mg) | Ratio of UACR at Day 90 to UACR at Baseline | 0.89 Ratio | 90% Confidence Interval 0.786 |
| Finerenone (BAY94-8862) (5 mg) | Ratio of UACR at Day 90 to UACR at Baseline | 0.824 Ratio | 90% Confidence Interval 0.73 |
| Finerenone (BAY94-8862) (7.5 mg) | Ratio of UACR at Day 90 to UACR at Baseline | 0.739 Ratio | 90% Confidence Interval 0.653 |
| Finerenone (BAY94-8862) (10 mg) | Ratio of UACR at Day 90 to UACR at Baseline | 0.708 Ratio | 90% Confidence Interval 0.627 |
| Finerenone (BAY94-8862) (15 mg) | Ratio of UACR at Day 90 to UACR at Baseline | 0.63 Ratio | 90% Confidence Interval 0.563 |
| Finerenone (BAY94-8862) (20 mg) | Ratio of UACR at Day 90 to UACR at Baseline | 0.585 Ratio | 90% Confidence Interval 0.523 |
| Placebo | Ratio of UACR at Day 90 to UACR at Baseline | 0.938 Ratio | 90% Confidence Interval 0.829 |
Comparison: To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.p-value: 0.197390% CI: [0.799, 1.074]t-test, 1 sided
Comparison: To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.p-value: 0.280890% CI: [0.818, 1.101]t-test, 1 sided
Comparison: To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.p-value: 0.072390% CI: [0.758, 1.017]t-test, 1 sided
Comparison: To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.p-value: 0.003990% CI: [0.68, 0.912]t-test, 1 sided
Comparison: To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.p-value: 0.000990% CI: [0.651, 0.875]t-test, 1 sided
Comparison: To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.p-value: <0.000190% CI: [0.584, 0.772]t-test, 1 sided
Comparison: To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.p-value: <0.000190% CI: [0.542, 0.718]t-test, 1 sided
Secondary
Change From Baseline to Day 90 in eGFR
An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Time frame: Baseline and Day 90±2
Population: Participants in SAF with valid data for this endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Finerenone (BAY94-8862) (1.25 mg) | Change From Baseline to Day 90 in eGFR | -2.364 mL/min/1.73m^2 | 95% Confidence Interval -4.311 |
| Finerenone (BAY94-8862) (2.5 mg) | Change From Baseline to Day 90 in eGFR | -3.189 mL/min/1.73m^2 | 95% Confidence Interval -5.164 |
| Finerenone (BAY94-8862) (5 mg) | Change From Baseline to Day 90 in eGFR | -2.497 mL/min/1.73m^2 | 95% Confidence Interval -4.475 |
| Finerenone (BAY94-8862) (7.5 mg) | Change From Baseline to Day 90 in eGFR | -3.378 mL/min/1.73m^2 | 95% Confidence Interval -5.341 |
| Finerenone (BAY94-8862) (10 mg) | Change From Baseline to Day 90 in eGFR | -4.192 mL/min/1.73m^2 | 95% Confidence Interval -6.181 |
| Finerenone (BAY94-8862) (15 mg) | Change From Baseline to Day 90 in eGFR | -3.806 mL/min/1.73m^2 | 95% Confidence Interval -5.563 |
| Finerenone (BAY94-8862) (20 mg) | Change From Baseline to Day 90 in eGFR | -4.024 mL/min/1.73m^2 | 95% Confidence Interval -5.792 |
| Placebo | Change From Baseline to Day 90 in eGFR | -1.578 mL/min/1.73m^2 | 95% Confidence Interval -3.53 |
p-value: 0.545495% CI: [-3.337, 1.765]t-test, 2 sided
p-value: 0.218695% CI: [-4.177, 0.957]t-test, 2 sided
p-value: 0.485995% CI: [-3.503, 1.667]t-test, 2 sided
p-value: 0.167795% CI: [-4.358, 0.759]t-test, 2 sided
p-value: 0.046295% CI: [-5.183, -0.044]t-test, 2 sided
p-value: 0.070595% CI: [-4.643, 0.187]t-test, 2 sided
p-value: 0.04895% CI: [-4.869, -0.022]t-test, 2 sided
Secondary
Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)
EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state).
Time frame: Baseline and Day 90±2
Population: Participants in FAS with valid data for this endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Finerenone (BAY94-8862) (1.25 mg) | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 1.381 scores on a scale | 95% Confidence Interval -1.22 |
| Finerenone (BAY94-8862) (2.5 mg) | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 3.888 scores on a scale | 95% Confidence Interval 1.208 |
| Finerenone (BAY94-8862) (5 mg) | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 3.124 scores on a scale | 95% Confidence Interval 0.494 |
| Finerenone (BAY94-8862) (7.5 mg) | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 2.851 scores on a scale | 95% Confidence Interval 0.241 |
| Finerenone (BAY94-8862) (10 mg) | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 2.698 scores on a scale | 95% Confidence Interval 0.026 |
| Finerenone (BAY94-8862) (15 mg) | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 2.743 scores on a scale | 95% Confidence Interval 0.394 |
| Finerenone (BAY94-8862) (20 mg) | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 1.914 scores on a scale | 95% Confidence Interval -0.465 |
| Placebo | Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale) | 4.425 scores on a scale | 95% Confidence Interval 1.794 |
p-value: 0.081695% CI: [-6.471, 0.383]t-test, 2 sided
p-value: 0.762595% CI: [-4.027, 2.953]t-test, 2 sided
p-value: =0.460395% CI: [-4.759, 2.157]t-test, 2 sided
p-value: 0.367895% CI: [-5.004, 1.855]t-test, 2 sided
p-value: 0.327995% CI: [-5.191, 1.736]t-test, 2 sided
p-value: 0.310295% CI: [-4.935, 1.57]t-test, 2 sided
p-value: 0.131795% CI: [-5.778, 0.755]t-test, 2 sided
Secondary
Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)
The Kidney Disease QOL \[KDQOL\]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). Effects of Kidney disease subscore was analyzed.
Time frame: Baseline and Day 90±2
Population: Participants in FAS with valid data for this endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Finerenone (BAY94-8862) (1.25 mg) | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | -2.116 scores on a scale | 95% Confidence Interval -4.521 |
| Finerenone (BAY94-8862) (2.5 mg) | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | 0.104 scores on a scale | 95% Confidence Interval -2.369 |
| Finerenone (BAY94-8862) (5 mg) | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | -1.229 scores on a scale | 95% Confidence Interval -3.643 |
| Finerenone (BAY94-8862) (7.5 mg) | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | -1.185 scores on a scale | 95% Confidence Interval -3.597 |
| Finerenone (BAY94-8862) (10 mg) | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | -2.596 scores on a scale | 95% Confidence Interval -5.049 |
| Finerenone (BAY94-8862) (15 mg) | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | 0.112 scores on a scale | 95% Confidence Interval -2.054 |
| Finerenone (BAY94-8862) (20 mg) | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | 0.058 scores on a scale | 95% Confidence Interval -2.146 |
| Placebo | Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease) | 0.747 scores on a scale | 95% Confidence Interval -1.684 |
p-value: 0.231395% CI: [-5.098, 1.234]t-test, 2 sided
p-value: 0.075795% CI: [-6.022, 0.297]t-test, 2 sided
p-value: 0.694195% CI: [-3.851, 2.565]t-test, 2 sided
p-value: 0.222895% CI: [-5.155, 1.203]t-test, 2 sided
p-value: 0.038695% CI: [-6.509, -0.176]t-test, 2 sided
p-value: 0.67795% CI: [-3.624, 2.355]t-test, 2 sided
p-value: 0.653695% CI: [-3.699, 2.322]t-test, 2 sided
Secondary
Change From Baseline to Day 90 in Serum Potassium
Time frame: Baseline and Day 90±2
Population: Participants in SAF with valid data for this endpoint
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Finerenone (BAY94-8862) (1.25 mg) | Change From Baseline to Day 90 in Serum Potassium | 0.109 millimole per liter |
| Finerenone (BAY94-8862) (2.5 mg) | Change From Baseline to Day 90 in Serum Potassium | 0.123 millimole per liter |
| Finerenone (BAY94-8862) (5 mg) | Change From Baseline to Day 90 in Serum Potassium | 0.202 millimole per liter |
| Finerenone (BAY94-8862) (7.5 mg) | Change From Baseline to Day 90 in Serum Potassium | 0.127 millimole per liter |
| Finerenone (BAY94-8862) (10 mg) | Change From Baseline to Day 90 in Serum Potassium | 0.167 millimole per liter |
| Finerenone (BAY94-8862) (15 mg) | Change From Baseline to Day 90 in Serum Potassium | 0.238 millimole per liter |
| Finerenone (BAY94-8862) (20 mg) | Change From Baseline to Day 90 in Serum Potassium | 0.188 millimole per liter |
| Placebo | Change From Baseline to Day 90 in Serum Potassium | 0.002 millimole per liter |
p-value: 0.042895% CI: [0.003, 0.21]t-test, 2 sided
p-value: 0.022395% CI: [0.017, 0.225]t-test, 2 sided
p-value: 0.000295% CI: [0.096, 0.305]t-test, 2 sided
p-value: 0.018195% CI: [0.021, 0.229]t-test, 2 sided
p-value: 0.001995% CI: [0.061, 0.27]t-test, 2 sided
p-value: <0.000195% CI: [0.137, 0.334]t-test, 2 sided
p-value: 0.000295% CI: [0.088, 0.284]t-test, 2 sided