Kidney Disease, Chronic
Conditions
Brief summary
This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
DRUGPlacebo to BI 690517
Film-coated tablets
DRUGEmpagliflozin
Empagliflozin
DRUGBI 690517
Film-coated tablets
Placebo to empagliflozin
Sponsors
Boehringer Ingelheim
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
* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. * Male or female patients of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent. * estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) ≥ 30 and \< 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis. * Urine Albumin Creatinine Ratio (UACR) ≥ 200 and \< 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1 * If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent). * Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial. * In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation. * Glycated Haemoglobin (HbA1c) \< 10.0% at Visit 1 measured by the central laboratory. * Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory. * Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement. * Body Mass Index (BMI) ≥ 18.5 and \< 50 kg/m2 at Visit 1. * Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP. Additional inclusion criteria to be assessed before second randomisation (start of Treatment Period): * Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period. * eGFR (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
Exclusion criteria
* Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase. * Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded. * Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA)) * Patients at increased risk of ketoacidosis in the opinion of the investigator. * Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. | The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient. |
| Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. | Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient. |
| Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. | The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient. |
| Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. | Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient. |
| Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. | The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient. |
| Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. | Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach. | Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach. | Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach. | Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach. | Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF) | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach. | Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach. | Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach. | Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach. | Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach. | Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach. | Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available. |
| UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF) | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach. | Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach. | Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression. |
| UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period. | Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Finland, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United States
Participant flow
Recruitment details
The trial included two randomisations, R1 and R2. At first randomisation R1, patients were 1:1 randomised to a run-in period of 8 weeks and received 10 mg empagliflozin or placebo matching empagliflozin. The run-in period was followed by randomisation R2 at which patients were 1:1:1:1 randomized to a treatment period of 14 weeks to receive one of three doses of BI 690517 or placebo matching BI 690517 in combination with the background medication assigned in the randomized run-in period.
Pre-assignment details
2 patients of the arm Run-in period: Placebo to empagliflozin 10 mg who did not complete the Run-in period (RP) were mistakenly randomized to the treatment period (TP) but were not treated during the TP with BI 690517 or placebo to BI 690517.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 3 mg BI 690517 and 10 mg empagliflozin for 14 weeks. | 76 |
| Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 10 mg BI 690517 and 10 mg empagliflozin for 14 weeks. | 74 |
| Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 milligrams (mg) of BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received 20 mg BI 690517 and 10 mg empagliflozin for 14 weeks. | 74 |
| Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517 This arm includes patients who received 10 mg of empagliflozin during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with 10 mg of empagliflozin QD orally. Patients received placebo matching BI 690517 and 10 mg empagliflozin for 14 weeks. | 74 |
| Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 3 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 3 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks. | 71 |
| Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 10 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 10 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks. | 72 |
| Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received 20 mg of BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received 20 mg BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks. | 72 |
| Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517 This arm includes patients who received placebo matching empagliflozin 10 milligrams (mg) during the run-in period and met the eligibility criteria to enter the treatment period.
In the treatment period patients received placebo matching BI 690517 once daily (QD) orally in combination with placebo matching empagliflozin 10 mg QD orally. Patients received placebo matching BI 690517 and placebo matching empagliflozin 10 mg for 14 weeks. | 73 |
| Total | 586 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed RP and Randomized to TP | Did not meet additional inclusion/exclusion criteria for Treatment Period | 34 | 44 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-in Period | Adverse Event | 5 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-in Period | Burden of study procedures | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-in Period | Change of residence | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-in Period | No reason available | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-in Period | Not treated | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Run-in Period | Other reason but not sponsor termination | 14 | 18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Adverse Event | 0 | 0 | 4 | 16 | 12 | 6 | 4 | 8 | 16 | 5 |
| Treatment Period | Burden of study procedures | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period | Change of residence | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Treatment Period | No reason available | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 1 | 0 | 0 |
| Treatment Period | Not treated with study drug | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Treatment Period | Other but not sponsor termination | 0 | 0 | 8 | 6 | 6 | 7 | 5 | 8 | 7 | 2 |
| Treatment Period | Protocol deviation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Period | Reason missing | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517 | Total | Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517 | Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517 | Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517 | Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517 | Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517 | Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517 | Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 65.4 Years STANDARD_DEVIATION 11.2 | 63.8 Years STANDARD_DEVIATION 11.3 | 62.3 Years STANDARD_DEVIATION 11.4 | 64.3 Years STANDARD_DEVIATION 10.7 | 64.8 Years STANDARD_DEVIATION 9.9 | 64.4 Years STANDARD_DEVIATION 11.8 | 63.4 Years STANDARD_DEVIATION 10.3 | 61.8 Years STANDARD_DEVIATION 12.2 | 64.4 Years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 163 Participants | 24 Participants | 18 Participants | 21 Participants | 22 Participants | 20 Participants | 12 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 423 Participants | 49 Participants | 54 Participants | 51 Participants | 49 Participants | 54 Participants | 62 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 13 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 156 Participants | 16 Participants | 19 Participants | 15 Participants | 23 Participants | 19 Participants | 20 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 63 Participants | 10 Participants | 9 Participants | 9 Participants | 3 Participants | 10 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 11 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 342 Participants | 44 Participants | 40 Participants | 45 Participants | 42 Participants | 42 Participants | 45 Participants | 35 Participants |
| Sex: Female, Male Female | 27 Participants | 196 Participants | 18 Participants | 27 Participants | 23 Participants | 20 Participants | 31 Participants | 20 Participants | 30 Participants |
| Sex: Female, Male Male | 49 Participants | 390 Participants | 55 Participants | 45 Participants | 49 Participants | 51 Participants | 43 Participants | 54 Participants | 44 Participants |
| Urine Albumin Creatinine Ratio (UACR) at baseline | 780.3 milligram/gram STANDARD_DEVIATION 828.8 | 757.9 milligram/gram STANDARD_DEVIATION 930.5 | 684.4 milligram/gram STANDARD_DEVIATION 715.1 | 785.0 milligram/gram STANDARD_DEVIATION 885.7 | 646.2 milligram/gram STANDARD_DEVIATION 685.2 | 934.0 milligram/gram STANDARD_DEVIATION 1363.6 | 801.4 milligram/gram STANDARD_DEVIATION 1132.3 | 695.4 milligram/gram STANDARD_DEVIATION 748 | 740.8 milligram/gram STANDARD_DEVIATION 915 |
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 | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 356 | 2 / 357 | 1 / 76 | 1 / 73 | 0 / 74 | 2 / 74 | 0 / 70 | 1 / 71 | 1 / 72 | 0 / 73 |
| other Total, other adverse events | 17 / 356 | 15 / 357 | 11 / 76 | 20 / 73 | 19 / 74 | 13 / 74 | 15 / 70 | 16 / 71 | 25 / 72 | 9 / 73 |
| serious Total, serious adverse events | 9 / 356 | 20 / 357 | 4 / 76 | 7 / 73 | 5 / 74 | 7 / 74 | 3 / 70 | 4 / 71 | 6 / 72 | 3 / 73 |
Outcome results
Primary
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin
The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Time frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Population: All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 3 mg BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin | -0.210 log (milligram/gram) |
| 10 mg BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin | -0.614 log (milligram/gram) |
| 20 mg BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin | -0.516 log (milligram/gram) |
| Placebo to BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin | -0.112 log (milligram/gram) |
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0.373795% CI: [-0.316, 0.119]MMRM
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: <0.000195% CI: [-0.73, -0.275]MMRM
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0.000495% CI: [-0.625, -0.184]MMRM
Primary
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin
The adjusted mean change (95% confidence interval) in log transformed first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline at 14 weeks for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Time frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Population: All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 3 mg BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin | -0.254 log (milligram/gram) |
| 10 mg BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin | -0.496 log (milligram/gram) |
| 20 mg BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin | -0.455 log (milligram/gram) |
| Placebo to BI 690517 | Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin | -0.027 log (milligram/gram) |
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0.086795% CI: [-0.488, 0.033]MMRM
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0.000795% CI: [-0.737, -0.201]MMRM
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0.002795% CI: [-0.707, -0.151]MMRM
Primary
Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients
The adjusted mean change (95% confidence interval) in log transformed FMV UACR from baseline at 14 weeks is presented. The adjusted means and 95 % confidence intervals were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which includes the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Time frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 3 mg BI 690517 | Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients | -0.235 log (milligram/gram) |
| 10 mg BI 690517 | Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients | -0.553 log (milligram/gram) |
| 20 mg BI 690517 | Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients | -0.487 log (milligram/gram) |
| Placebo to BI 690517 | Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients | -0.066 log (milligram/gram) |
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0.049995% CI: [-0.337, 0]MMRM
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: <0.000195% CI: [-0.66, -0.313]MMRM
Comparison: The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: <0.000195% CI: [-0.596, -0.246]MMRM
Comparison: A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0MCPMod Emax model fit
Comparison: A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0MCPMod linear model fit
Comparison: A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod). MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.p-value: 0.0003MCPMod exponential model fit
Primary
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for all patients is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Time frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 3 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients | -20.9 percent change of FMV UACR |
| 10 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients | -42.5 percent change of FMV UACR |
| 20 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients | -38.5 percent change of FMV UACR |
| Placebo to BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients | -6.4 percent change of FMV UACR |
95% CI: [-28.6, 0]
95% CI: [-48.3, -26.8]
95% CI: [-44.9, -21.8]
Primary
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of placebo matching empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Time frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Population: All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 3 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin | -22.4 percent change of FMV UACR |
| 10 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin | -39.1 percent change of FMV UACR |
| 20 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin | -36.6 percent change of FMV UACR |
| Placebo to BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - Patients With Background Therapy of Placebo Matching Empagliflozin | -2.6 percent change of FMV UACR |
95% CI: [-38.6, 3.4]
95% CI: [-52.2, -18.2]
95% CI: [-50.7, -14]
Primary
Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin
Percent change of first morning void (FMV) urine albumine creatinine ratio (UACR) from baseline to Week 14 based on adjusted median (95% confidence interval (CI)) back transformed from mixed models for repeated measures (MMRM) estimate for patients with background therapy of empagliflozin in the Run-in period is presented. Percent change of FMV UACR= (FMV UACR at Week 14-FMV UACR at baseline)\*100/(FMV UACR at baseline). MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.
Time frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period.
Population: All randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 3 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin | -19.0 percent change of FMV UACR |
| 10 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin | -45.9 percent change of FMV UACR |
| 20 mg BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin | -40.3 percent change of FMV UACR |
| Placebo to BI 690517 | Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) of MMRM Estimate - Patients With Background Therapy of Empagliflozin | -10.6 percent change of FMV UACR |
95% CI: [-27.1, 12.7]
95% CI: [-51.8, -24]
95% CI: [-46.5, -16.8]
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.~LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 45 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 67 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 73 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 31 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.034895% CI: [1.04, 3.09]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.4, 7.08]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.91, 8.67]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 40 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 62 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 57 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 23 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.011195% CI: [1.19, 3.88]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [3.49, 11.49]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.88, 9.44]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 (3mg QD, 10 mg QD or 20 mg QD) or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.~The missing as non-responder imputes patients with missing Week 14 data as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 40 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 62 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 57 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 23 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.011195% CI: [1.19, 3.88]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [3.49, 11.49]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.88, 9.44]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation
Number of patients with UACR response I is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Population: Full Analysis Set (FAS): This patient set included all randomised patients who had at least one baseline measurement of UACR at Week -2, -1, or 0 and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.~The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation | 40 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation | 73 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation | 66 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Multiple Imputation | 24 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.013695% CI: [1.16, 3.72]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [3.94, 12.49]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [3.09, 9.71]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 21 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 34 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 32 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 14 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.188495% CI: [0.77, 3.79]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.94, 15.72]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000395% CI: [2, 9.94]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.~LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 23 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 36 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 41 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 17 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.21495% CI: [0.76, 3.46]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000395% CI: [1.93, 8.85]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.52, 11.71]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 21 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 34 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 32 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 14 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.188495% CI: [0.77, 3.79]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.94, 15.72]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000395% CI: [2, 9.94]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Number of patients with UACR response I for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Population: All randomised patients to of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 21 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 42 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 36 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 14 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.139895% CI: [0.82, 4.04]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [3.73, 19.02]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000195% CI: [2.28, 10.9]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received placebo matching empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 19 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 28 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 25 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 9 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.019595% CI: [1.19, 7.02]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.65, 15.35]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000195% CI: [2.6, 15.67]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 19 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 28 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 25 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 9 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.019595% CI: [1.19, 7.02]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.65, 15.35]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000195% CI: [2.6, 15.67]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo to BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo to BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 19 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 31 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 30 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 10 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.041995% CI: [1.03, 5.74]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.64, 14.08]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.64, 14.25]Regression, Logistic
Secondary
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response I for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response I was defined as decrease of at least 30% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 22 Participants |
| 10 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 31 Participants |
| 20 mg BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 32 Participants |
| Placebo to BI 690517 | UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 14 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.076795% CI: [0.93, 4.42]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000395% CI: [1.89, 8.91]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000195% CI: [2.15, 10.24]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 67 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 71 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 70 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis | 44 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.001995% CI: [1.35, 3.77]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.2, 6.59]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.12, 6.35]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.~LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 67 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 87 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 85 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Last Observation on Treatment Carried Forward (LOCF) | 53 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.041895% CI: [1.02, 2.74]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.3, 6.65]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.11, 6.05]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.~The missing as non-responder imputes patients with missing Week 14 data as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 67 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 71 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 70 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Missing as Non-Responder | 44 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.001995% CI: [1.35, 3.77]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.2, 6.59]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.12, 6.35]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation
Number of patients with UACR response II is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 week. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Population: Full Analysis Set (FAS): This patient set included all randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6, 7 or 8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517.~The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation | 68 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation | 82 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation | 81 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients -Multiple Imputation | 46 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.002495% CI: [1.32, 3.61]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.39, 6.86]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.29, 6.55]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 35 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 39 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 38 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Complete Case Analysis | 24 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.057895% CI: [0.98, 4.14]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000195% CI: [2.23, 11.78]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.002295% CI: [1.54, 7.16]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Last observation on treatment carried forward (LOCF) uses the last value observed on treatment to substitute all missing values until Week 14.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 39 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 46 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 44 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Last Observation on Treatment Carried Forward | 28 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.034295% CI: [1.06, 4.44]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000395% CI: [1.93, 9.24]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.002395% CI: [1.52, 6.73]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 35 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 39 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 38 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Missing as Non-Responder | 24 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.057895% CI: [0.98, 4.14]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000195% CI: [2.23, 11.78]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.002295% CI: [1.54, 7.16]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation
Number of patients with UACR response II for patients with background therapy of empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 35 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 47 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 42 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Empagliflozin - Multiple Imputation | 24 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.034895% CI: [1.06, 4.43]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 095% CI: [2.73, 13.57]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000795% CI: [1.71, 7.52]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. Complete case analysis used patients with both baseline and Week 14 data available.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who had received placebo matching empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (i.e. Week 6, 7 or 8 of Run-in period) and one post-baseline measurement at Week 12-14 when patients were still on treatment with BI 690517 or placebo matching BI 690517.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 32 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 32 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 32 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks -Patients With Background Therapy of Placebo Matching Empagliflozin - Complete Case Analysis | 20 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.011695% CI: [1.23, 5.31]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.003295% CI: [1.46, 6.52]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000495% CI: [1.86, 8.91]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
Time frame: At baseline (Week 6,7 or 8 of the Run-in period) and at Week 12-14 of the Treatment Period.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. The missing as non-responder imputes patients with missing Week 14 data as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 32 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 32 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 32 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Missing as Non-Responder | 20 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.011695% CI: [1.23, 5.31]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.003295% CI: [1.46, 6.52]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000495% CI: [1.86, 8.91]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the multiple imputation approach.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo to BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo to BI 690517. The multiple imputation filled in missing values at Week 14 based on other data observed in the same patient using regression.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 33 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 35 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 39 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - Patients With Background Therapy of Placebo Matching Empagliflozin - Multiple Imputation | 22 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.028595% CI: [1.09, 4.45]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.003895% CI: [1.41, 5.96]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000295% CI: [1.97, 8.72]Regression, Logistic
Secondary
UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
Number of patients with UACR response II for patients with background therapy of placebo matching empagliflozin in the Run-in period is reported. UACR response II was defined as decrease of at least 15% absolute change in First Morning Void (FMV) urine of UACR from treatment period baseline to 14 weeks. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
Time frame: UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period were used for the last observation carried forward approach.
Population: All randomised patients to one of 3 doses of BI 690517 or placebo matching BI 690517 who received placebo to empagliflozin during the Run-in Period and who had at least one baseline measurement of UACR at Week -2, -1, or 0 (Week 6,7,8 of the Run-in Period) and at least one post-baseline measurement when patients were still on treatment with BI 690517 or placebo matching BI 690517. LOCF uses the last value observed on treatment to substitute all missing values until Week 14.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 28 Participants |
| 10 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 41 Participants |
| 20 mg BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 41 Participants |
| Placebo to BI 690517 | UACR Response II, Defined as Decrease of at Least 15% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF) | 25 Participants |
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.409295% CI: [0.67, 2.69]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000595% CI: [1.77, 7.58]Regression, Logistic
Comparison: The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening.p-value: 0.000295% CI: [1.92, 8.49]Regression, Logistic