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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002929-28 | EudraCT Number |
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This study is open to adults with diabetic kidney disease. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study.
Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for diabetes and kidney disease throughout the study.
Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 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.
Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| BI 685509 1 mg TID | Experimental |
| |
| BI 685509 2 mg TID | Experimental | Low dose followed by up-titration to medium dose. |
|
| BI 685509 3 mg TID | Experimental | Low dose followed by up-titration to medium dose, followed by up-titration to high-dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo matching BI 685509 | Drug | film-coated tablet |
| |
| BI 685509 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment | Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) after 20 weeks is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported. | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void Urine After 20 Weeks of Trial Treatment | Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported. |
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Inclusion criteria:
Further inclusion criteria apply.
Exclusion criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kidney & Hypertension Center | Victorville | California | 92395 | United States | ||
| Chase Medical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38795055 | Derived | Heerspink HJL, Cherney D, Gafor AHA, Gorriz JL, Pergola PE, Tang SCW, Desch M, Iliev H, Sun Z, Steubl D, Nangaku M. Effect of Avenciguat on Albuminuria in Patients with CKD: Two Randomized Placebo-Controlled Trials. J Am Soc Nephrol. 2024 Sep 1;35(9):1227-1239. doi: 10.1681/ASN.0000000000000418. Epub 2024 May 25. |
| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This study was a phase II, randomized, double-blind (within dose groups), placebo controlled and parallel group trial in patients with diabetic kidney disease (DKD) to demonstrate the effectiveness of BI 685509 and to characterize the dose-response relationship for BI 685509 in patients with DKD by assessing 3 doses and placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 685509 1 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2022 | May 28, 2024 |
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Multicentre, randomised, double-blind (within dose groups), parallel, placebo-controlled trial. Patients will be randomised equally into one of three parallel dose groups, and in each dose group to treatment either with BI 685509 or matching placebo in a 3:1 ratio.
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| Drug |
film-coated tablet |
|
|
| The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20. |
| Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment | Number of patients achieving Urine Albumin Creatinine Ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. | Baseline (day -14 and -7) and week 20 (day 141). |
| Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment | Number of patients achieving Albumin Creatinine Ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment. is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. | Baseline (day -14 and -7) and week 20 (day 141). |
| Waterbury |
| Connecticut |
| 06708 |
| United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | United States |
| Davita Clinical Research | Columbus | Georgia | 31904 | United States |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | United States |
| Research by Design, LLC | Chicago | Illinois | 60643 | United States |
| DaVita Clinical Research | Las Vegas | Nevada | 89128 | United States |
| Total Renal Research | The Bronx | New York | 10461 | United States |
| Brookview Hills Research Associates LLC | Winston-Salem | North Carolina | 27103 | United States |
| Knoxville Kidney Center PLLC | Knoxville | Tennessee | 37923 | United States |
| DaVita Clinical Research | Houston | Texas | 77054 | United States |
| Texas Institute for Kidney and Endocrine Disorders | Lufkin | Texas | 75904 | United States |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | United States |
| DaVita Clinical Research | San Antonio | Texas | 78240 | United States |
| Kidney Specialists of North Houston, PLLC | Shenandoah | Texas | 77384 | United States |
| Tidewater Kidney Specialists | Norfolk | Virginia | 23510 | United States |
| CEDIC - Centro de Investigacion Clinica | CABA | C1060ABN | Argentina |
| Instituto Médico Especializado | Capital Federal | C1405BCH | Argentina |
| Instituto Privado de Investigaciones ClÃnica Córdoba S.A. | Córdoba | X5000AAW | Argentina |
| Centro de Investigaciones Médicas Mar del Plata | Mar del Plata | B7600FYK | Argentina |
| Instituto Médico Catamarca - IMEC | Rosario | S2000AJU | Argentina |
| CEREHA S.A.- Centro de Estudios Renales e Hipertensión Arterial | Sarandà | B1872EEB | Argentina |
| Renal Research, Gosford | Gosford | New South Wales | 2250 | Australia |
| Nepean Hospital | Kingswood | New South Wales | 2747 | Australia |
| Macquarie University | Macquarie Park | New South Wales | 2109 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| CARe Clinic | Red Deer | Alberta | T4P 1K4 | Canada |
| Albion Finch Medical Centre | Toronto | Ontario | M9V 4B4 | Canada |
| Fadia El Boreky Medicine Professional | Waterloo | Ontario | N2J 1C4 | Canada |
| Peking University First Hospital | Beijing | 100034 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Second Affiliated Hospital Chongqing Medical University | Chongqing | 400016 | China |
| People's Hospital of Sichuan Province | Sichuan | 610031 | China |
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
| Sjællands Universitetshospital | Roskilde | 4000 | Denmark |
| Prince of Wales Hospital | Hong Kong | 999077 | Hong Kong |
| Queen Mary Hospital | Hong Kong | 999077 | Hong Kong |
| Tung Wah Hospital | Hong Kong | Hong Kong |
| Chubu Rosai Hospital | Aichi, Nagoya | 455-8530 | Japan |
| Daido Hospital | Aichi, Nagoya | 457-8511 | Japan |
| Kurume University Hospital | Fukuoka, Kurume | 830-0011 | Japan |
| Nakayamadera Imai Clinic | Hyogo, Takarazuka | 665-0861 | Japan |
| Takai Naika Clinic | Kanagawa, Kamakura | 247-0056 | Japan |
| Kawasaki Medical School Hospital | Okayama, Kurashiki | 701-0192 | Japan |
| Osaka General Medical Center | Osaka, Osaka | 558-8558 | Japan |
| OCROM Clinic | Osaka, Suita | 565-0853 | Japan |
| Saitama Medical University Hospital | Saitama, Iruma-gun | 350-0495 | Japan |
| The University of Tokyo Hospital | Tokyo, Bunkyo-ku | 113-8655 | Japan |
| Tokyo-Eki Center-building Clinic | Tokyo, Chuo-ku | 103-0027 | Japan |
| ToCROM Clinic | Tokyo, Shinjyuku-ku | 160-0008 | Japan |
| University Kebangsaan Malaysia | Cheras, Kuala Lumpur | 56000 | Malaysia |
| Universiti Sains Malaysia Hospital | Kelantan | 16150 | Malaysia |
| University of Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital Selayang | Kuala Selangor | 68100 | Malaysia |
| Hospital Cardiologica Aguascalientes | Aguascalientes | 20230 | Mexico |
| Centenario Hospital Miguel Hidalgo | Aguascalientes | 20259 | Mexico |
| Clinstile S.A. de C.V. | México | 06700 | Mexico |
| Hospital Universitario Dr Jose Eleuterio Gonzalez | Monterrey | 64460 | Mexico |
| Albert SchweitzerZiekenhuis | Dordrecht | 3318 AT | Netherlands |
| Universitair Medisch Centrum Utrecht | GA Utrecht | 3508 | Netherlands |
| P3 Research Kapiti | Paraparaumu | 5032 | New Zealand |
| P3 Research | Tauranga | 3110 | New Zealand |
| SPECDERM Poznanska General Partnership | Bialystok | 15-375 | Poland |
| Pratia MCM Krakow | Krakow | 30-510 | Poland |
| Medicome Limited Liability Company | Oświęcim | 32-600 | Poland |
| NBR Polska | Warsaw | 00710 | Poland |
| ULS da Região de Aveiro | Aveiro | 3810-164 | Portugal |
| APDP - Associação Protectora dos Diabéticos de Portugal | Lisbon | 1250-189 | Portugal |
| Hospital A Coruña | A Coruña | 15006 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Virgen Macarena | Seville | 41009 | Spain |
| Hospital ClÃnico de Valencia | Valencia | 46010 | Spain |
| University Hospital Coventry | Coventry | CV2 2DX | United Kingdom |
| Barts and The London School of Medicine and Dentistry | London | EC1M 6BQ | United Kingdom |
| BI 685509 2mg TID |
The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| FG002 | BI 685509 3 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| FG003 | Placebo | This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomised Set (RS): This patient set includes all entered and randomised patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 685509 1 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| BG001 | BI 685509 2mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| BG002 | BI 685509 3 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| BG003 | Placebo | This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Urine Albumin Creatinine Ratio (UACR) FMV | Urine Albumin Creatinine Ratio (UACR) at baseline. The first morning void (FMV) is the first urination after the patient wakes up at their usual time to start their day. Baseline is defined as the mean of all available samples prior to Visit 2 up to and including those prior to the first intake of trial medication. | Mean | Standard Deviation | Milligram/gram (mg/g) |
| ||||||||||||||
| Urine Albumin Creatinine Ratio (UACR) - 10 Hour | Urine Albumin Creatinine Ratio (UACR) at baseline. For 10-hour urine. Baseline was defined as the mean of all non-missing assessments from visit 2 until prior to the first intake of trial medication. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. | Mean | Standard Deviation | milligram/gram (mg/g) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment | Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) after 20 weeks is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported. | Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6. | Posted | Least Squares Mean | Standard Error | milligram/gram (mg/g) | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void Urine After 20 Weeks of Trial Treatment | Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Least Square Means and Standard error were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. The Least Squares Mean (Standard error) at Week 20 is reported. | Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6. | Posted | Least Squares Mean | Standard Error | milligram/gram (mg/g) | The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment | Number of patients achieving Urine Albumin Creatinine Ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment is reported. As soon as the First Morning Void sample was collected the clock starts for the 10-hour urine collection. During the 10-hour period every time the patient urinates, they collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample. | Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6. | Posted | Count of Participants | Participants | Baseline (day -14 and -7) and week 20 (day 141). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment | Number of patients achieving Albumin Creatinine Ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment. is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. | Full Analysis Set (FAS): The patient set included all patients who had at least one baseline measurement of UACR in week -2, -1, or 0 and at least one post-baseline measurement after week 6. | Posted | Count of Participants | Participants | Baseline (day -14 and -7) and week 20 (day 141). |
|
From first BI 685509 intake until last BI 685509 intake or patient's trial termination date, whichever occurs earlier + 7 days of Residual effect period (REP), up to 148 days.
Treated Set (TS): This set included all patients who were dispensed trial medication (BI 685509) and were documented to have taken at least 1 dose of open-label trial medication (BI 685509).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 685509 1 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during 20 weeks of treatment in total, with water and taken with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. | 0 | 61 | 4 | 61 | 13 | 61 |
| EG001 | BI 685509 2mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. | 1 | 61 | 8 | 61 | 15 | 61 |
| EG002 | BI 685509 3mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. | 2 | 61 | 7 | 61 | 15 | 61 |
| EG003 | Placebo | This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. | 0 | 58 | 4 | 58 | 14 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nodal rhythm | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Epiploic appendagitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic bullosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2023 | May 28, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient. |
| A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg). | MCP-Mod linear model fit | Model assumption: No assumption was needed. | 0.0294 | Other | MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient. |
| MCP-Mod quadratic model fit | Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg. | 0.0468 | MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient. | Other | A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg). |
| A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg). | MCP-Mod Emax model fit | Model assumption: 80% of the maximum effect is achieved at 6 mg. | 0.0586 | Other | MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient. |
| A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg). | MCP-Mod Sigmoid emax model fit | Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg. | 0.0659 | Other | MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient. |
| Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. | Mixed-effect Model Repeat Measurement | 0.3224 | Mean Difference (Net) | -0.103 | 2-Sided | 95 | -0.309 | 0.102 | Least Squares Mean of "1 mg BI 685509 TID"- Least Squares Mean of"Placebo" | Other |
| Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. | Mixed-effect Model Repeat Measurement | 0.5616 | Mean Difference (Net) | -0.063 | 2-Sided | 95 | -0.275 | 0.150 | Least Squares Mean of "2 mg BI 685509 TID"- Least Squares Mean of "Placebo" | Other |
| Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient. | Mixed-effect Model Repeat Measurement | 0.0183 | Mean Difference (Net) | -0.251 | 2-Sided | 95 | -0.459 | -0.043 | Least Squares Mean of "3 mg BI 685509 TID"- Least Squares Mean of "Placebo" | Other |
| OG001 | BI 685509 2mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 20 of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| OG002 | BI 685509 3 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| OG003 | Placebo | This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
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| OG002 | BI 685509 3 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| OG003 | Placebo | This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
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| OG002 | BI 685509 3 mg TID | The patients were administered 1 milligram (mg) BI 685509 Film-coated tablets 3 times a day during the first 2 weeks of treatment, If the medication was tolerated, up-titration to 2 mg TID BI 685509 occurred after 2 weeks until Week 4 of treatment. Then if medication was tolerated, up-titration to 3 mg TID BI 685509 occurred from Week 5 until Week 20. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
| OG003 | Placebo | This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered Film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first. |
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