> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-test-whether-different-doses-of-bi-690517-alone-36ea2b27-6965-490c-9275-1a4bd624ad30 > Record changed: 2026-10-13 # A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease NCT05182840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) Participants 714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) Start date 2022-01-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) Number of sites 203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Short title** A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Official title** Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Dates **Completion date** 2023-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **First posted** 2022-01-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Registry last updated** 2024-10-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Primary completion date** 2023-06-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Start date** 2022-01-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Size and sites **Actual participants** 714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Participants** 714 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Number of sites** 203 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Identifiers **Registry ID** NCT05182840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **ClinicalTrials.gov ID** NCT05182840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Outcomes ### Primary outcomes 1. 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 Timeframe: 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. 2. Percent Change of FMV UACR From Baseline to Week 14 Based on Adjusted Median (95% CI) Back Transformed From MMRM Estimate - All Patients Timeframe: 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. 3. Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin Timeframe: 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. 4. 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 Timeframe: 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. 5. Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin Timeframe: 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. 6. 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 Timeframe: 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 outcomes 1. 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 Timeframe: 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. 2. 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 Timeframe: 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. 3. 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) Timeframe: 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. 4. 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 Timeframe: 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. 5. 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 Timeframe: 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. 6. 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 Timeframe: 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. 7. 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) Timeframe: 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. 8. 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 Timeframe: 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. 9. 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 Timeframe: 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. 10. 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 Timeframe: 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. 11. 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 Timeframe: 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. 12. 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 Timeframe: 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. 13. 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 Timeframe: 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. 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 - All Patients - Missing as Non-Responder Timeframe: 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. 15. 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) Timeframe: 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. 16. 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 Timeframe: 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. 17. 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 Timeframe: 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. 18. 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 Timeframe: 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. 19. 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) Timeframe: 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. 20. 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 Timeframe: 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. 21. 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 Timeframe: 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. 22. 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 Timeframe: 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. 23. 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 Timeframe: 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. 24. 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 Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Sites - Aventiv Research Inc.Mesa, United States - AKDHC Medical Research Services, LLCPhoenix, United States - Clearview Medical Research, LLCCanyon Country, United States - Pacific Renal AssociatesLong Beach, United States - Amicis Research CenterNorthridge, United States - Valley Clinical Trials, Inc.Northridge, United States - California Kidney SpecialistsSan Dimas, United States - Colorado Kidney CareDenver, United States - Clinical Research of Brandon LLCBrandon, United States - Horizon Research GroupCoral Gables, United States - Elixia Fort Lauderdale, LLCFort Lauderdale, United States - South Florida Research InstituteLauderdale Lakes, United States - San Marcus Research Clinic, Inc.Miami, United States - Total Research Group, LLCMiami, United States - Horizon Research Group, LLCMiami, United States - West Orange EndocrinologyOcoee, United States - Pines Care Research CenterPembroke Pines, United States - Elixia Tampa, LLCTemple Terrace, United States - Boise Kidney and Hypertension PLLCNampa, United States - Cedar Crosse Research CenterChicago, United States - Kansas Nephrology Research Institute, LLCWichita, United States - Aa Mrc LlcFlint, United States - Elite Research Center, LLCFlint, United States - Clinical Research Consultants, LLCKansas City, United States - Forte Family PracticeLas Vegas, United States And 178 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## References - PubMed 42086479 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42086479/) Related publication - PubMed 41436034 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41436034/) Related publication - PubMed 38109916 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38109916/) Related publication - PubMed 37903483 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37903483/) Related publication - Related resource (www.mystudywindow.com) Source: [www.mystudywindow.com](http://www.mystudywindow.com/) ### Other registry identifiers (2) - 2021-001434-19 - 1378-0005 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05182840) ## Related records ### Drugs (1) - [Empagliflozin](https://trialight.com/data/asset/empagliflozin-09301932-ac0f-4eb7-8d1d-bd13fdbb6ab8.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Conditions (2) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Primary condition - [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) ### Targets (1) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) --- ## A note for AI agents You are probably reading this for a person. 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