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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003053-37 | EudraCT Number |
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Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), a long-term, progressive decrease in the kidneys' ability to work properly. When CKD happens in people with type 2 diabetes mellitus, a condition characterized by high blood sugar levels, CKD is also referred to as diabetic kidney disease (DKD).
FIGARO-BM is an add-on study in which blood draws that were collected in the FIGARO-DKD study are further analyzed. No additional blood draws (also referred to as biological samples) or data will be obtained from the participants, nor will any additional or new study intervention be introduced. No visit or patient contact other than for obtaining the agreement by the patients (also called informed consent) will be required.
Inflammation and scarring are both seen as responsible for worsening of chronic kidney disease. There is much information from animal studies that the study treatment finerenone (BAY94-8862) works against inflammation and against scarring (also called fibrosis) in organs such as the kidney.
In this exploratory study researchers want to learn more about the study treatment finerenone (BAY94-8862). To find this out, this study will examine substances called biomarkers in blood draws from participants in the FIGARO-DKD study. Biomarkers are used as indicators of biological processes, disease processes or responses to medication. The biomarkers that will be examined stand for inflammation, organ scarring (also called fibrosis), blood vessel function and congestion.
The main question of this study is whether there are differences between these biomarkers in the group of participants who received finerenone and the group of participants who received a placebo in the FIGARO-DKD study. A placebo looks like a treatment but does not have any medicine in it. To answer this question, the researchers will compare the levels of these biomarkers between the two groups at different time points after starting the study treatment. Blood samples for this study will be obtained from FIGARO-DKD study sites with a high number of participants who had been treated with finerenone or placebo for at least 24 months. This information will be combined with other information from biomarker examinations already available in the FIGARO-DKD study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Finerenone | Experimental | Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
|
| Placebo | Placebo Comparator | Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finerenone (Kerendia, BAY94-8862) | Drug | Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers | The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration. | At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Clinical Trials, Inc. - Northridge | Northridge | California | 91325 | United States | ||
| Saviers Medical Group |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Overall, 952 participants from previous FIGARO-DKD study (NCT02545049) were screened for this FIGAGRO-BM study. Of the 952 screened (i.e. signed informed consent available either for this FIGARO-BM study or for the protocol addendum for FIGARO-DKD), 1 participant was a screening failure and 30 participants missed treatment and/or biomarker data at Visit 3 or 11 in FIGARO-DKD. The remaining 921 participants were included in the modified biomarker full analysis set of FIGAGRO-BM study.
The study was conducted at multiple centers in 21 countries/regions between 18 August 2021 (first subject first visit) and 31 December 2021 (last subject last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Finerenone | Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
| FG001 | Placebo |
| 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 | Jun 24, 2021 | Dec 18, 2022 |
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| Placebo | Drug | Oral tablet; starting at 10 mg or 20 mg; once daily; received in previous interventional Phase 3 trial FIGARO-DKD; no new intervention was administered in this biomarker study. |
|
| Port Hueneme |
| California |
| 93041 |
| United States |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | United States |
| Florida Kidney Physicians - Fort Lauderdale | Fort Lauderdale | Florida | 33308 | United States |
| Indago Research & Health Center, Inc. | Hialeah | Florida | 33012 | United States |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | United States |
| Floridian Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Crescent City Clinical Research Center, LLC | Metairie | Louisiana | 70006 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | United States |
| Randolph Medical Associates | Asheboro | North Carolina | 27203 | United States |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212-4740 | United States |
| Illawarra Diabetes Service | Wollongong | New South Wales | 2500 | Australia |
| Melbourne Renal Research Group | Reservoir | Victoria | 3073 | Australia |
| Medizinische Universität Graz | Graz | Styria | 8036 | Austria |
| Klinik Landstraße - Krankenhaus Rudolfstiftung | Vienna | 1030 | Austria |
| Zentrum f. klinische Studien Dr. Hanusch GmbH | Vienna | 1060 | Austria |
| UZ Gent | Ghent | 9000 | Belgium |
| AZ Delta | Roeselaere | 8800 | Belgium |
| Multiprofile Hospital for Active Treatment St. Ivan Rilski - Gorna Oryahovitsa | Nephrology Department | Gorna Oryahovitsa | 5100 | Bulgaria |
| DCC 2 - Plovdiv EOOD | Plovdiv | 4002 | Bulgaria |
| MHAT Sveti Pantaleymon - Yambol | Yambol | 8600 | Bulgaria |
| Fraser Clinical Trials, Inc. | New Westminster | British Columbia | V3L 3W4 | Canada |
| Hopital Charles LeMoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Manna Research (Mirabel) | Mirabel | Quebec | J7J 2K8 | Canada |
| Clinique des Maladies Lipidques de Quebec | Québec | G1V 4W1 | Canada |
| Nefrologicka ambulance | Prague | 140 00 | Czechia |
| Aarhus Universitetshospital, Skejby | Aarhus N | 8200 | Denmark |
| Sydvestjysk Sygehus Esbjerg, Endocrinology dept. | Esbjerg | 6700 | Denmark |
| Capital Region | Gentofte Hospital - Cardiology Research | Hellerup | 2900 | Denmark |
| Herlev Hospital - Endocrinology dept. | Herlev | 2730 | Denmark |
| Steno Diabetes Center Copenhagen | Herlev | 2730 | Denmark |
| Holbæk Sygehus | Holbæk | 4300 | Denmark |
| Holstebro Hospital, Endocrinology dept. | Holstebro | DK-7500 | Denmark |
| Bispebjerg Hospital | København NV | 2400 | Denmark |
| Viborg Sygehus | Viborg | 8800 | Denmark |
| Terveystalo Oulu | Oulu | 90100 | Finland |
| Lääkärikeskus Minerva | Rauma | 26100 | Finland |
| Turun yliopistollinen keskussairaala | Turku | 20520 | Finland |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Prince of Wales Hospital Hong Kong | Shatin | Hong Kong |
| Tung Wah Hospital | Sheung Wan | Hong Kong |
| Barzilai Medical Center | Nephrology & Hypertension Dept. | Ashkelon | 7830604 | Israel |
| Edith Wolfson Medical Center | Holon | 5822012 | Israel |
| Hadassah Hebrew University Hospital Ein Kerem | Jerusalem | 9112001 | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| The Nazareth Trust Hospital EMMS | Nazareth | 16100 | Israel |
| Clalit Health Services, Midgal Hamea | Tel Aviv | 6203854 | Israel |
| DMC - Diabetes Medical Center | Tel Aviv | 6937947 | Israel |
| A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Istituto Ricerche Farmacologiche Mario Negri IRCCS | Bergamo | Lombardy | 24020 | Italy |
| ASST Papa Giovanni XXIII | Bergamo | Lombardy | 24127 | Italy |
| ASST Santi Paolo e Carlo | Milan | Lombardy | 20142 | Italy |
| Kohnodai Hospital, NC for Global Health and Medicine | Ichikawa | Chiba | 272-8516 | Japan |
| Saiseikai Matsuyama Hospital | Matsuyama | Ehime | 791-8026 | Japan |
| Fukuoka University Chikushi Hospital | Chikushino-shi | Fukuoka | 818-8502 | Japan |
| Fukuoka Tokushukai Hospital | Kasuga | Fukuoka | 816-0864 | Japan |
| Kokura Memorial Hospital | Kitakyushu | Fukuoka | 802-8555 | Japan |
| Steel Memorial Yawata Hospital | Kitakyushu | Fukuoka | 805-8508 | Japan |
| Shirakawa Kosei General Hospital | Shirakawa | Fukushima | 961-0005 | Japan |
| Higashihiroshima Medical Center | Higashihiroshima | Hiroshima | 739-0041 | Japan |
| Jiyugaoka YAMADA Clinic | Obihiro | Hokkaido | 080-0848 | Japan |
| Nakakinen Clinic | Naka | Ibaraki | 311-0113 | Japan |
| Noritake Clinic | Ushiku | Ibaraki | 300-1207 | Japan |
| Komatsu Municipal Hospital | Komatsu | Ishikawa-ken | 923-8560 | Japan |
| Shonan Fujisawa Tokushukai Hospital | Fujisawa | Kanagawa | 251-0041 | Japan |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
| Osaka Saiseikai Senri Hospital | Suita | Osaka | 565-0862 | Japan |
| Sugiura Clinic | Kawaguchi | Saitama | 332-0012 | Japan |
| Association of healthcare corporation, Oyama East Clinic | Oyama | Tochigi | 323-0022 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Japanese Red Cross Kumamoto Hospital | Kumamoto | 861-8520 | Japan |
| Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki | 852-8511 | Japan |
| Kyosokai AMC NISHI-UMEDA Clinic | Osaka | 530-0001 | Japan |
| Kitano Hospital | Osaka | 530-8480 | Japan |
| Albert Schweitzer Ziekenhuis, locatie Zwijndrecht | Zwijndrecht | 3331 LZ | Netherlands |
| Centro Clinico Academico - Braga | Braga | 4710-243 | Portugal |
| First City Clinical Hospital n.a. E.E. Volosevich | Arkhangelsk | 163001 | Russia |
| Izhevsk City Clinical Hospital #9 | Izhevsk | 426063 | Russia |
| Sci-Res. Institute of Complex Cardiovascular Disorders | Kemerovo | 650002 | Russia |
| Kemerovo Regional Clinical Hospital | Kemerovo | 650066 | Russia |
| Center of cardiology and neurology | Kirov | 610014 | Russia |
| Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky | Krasnodar | 350086 | Russia |
| Moscow State University n.a. M.V. Lomonosov | Moscow | 119192 | Russia |
| Moscow State Univ. of Med. & Stomatology n.a. A.I. Evdokimov | Moscow | 123182 | Russia |
| PHI "Central Clinical Hospital "RZD-Medicine" | Moscow | 125315 | Russia |
| City Clinical Hospital #13 Nizhny Novgorod | Nizhny Novgorod | 603018 | Russia |
| Saratov City Clinical Hospital #9 | Saratov | 410030 | Russia |
| Voronezh Regional Clinical Consultancy-Diagnostic Center | Voronezh | 394018 | Russia |
| City Outpatient Clinic #4 | Voronezh | 394077 | Russia |
| Clinical Hospital for Emergency Care n.a. N.V.Solovyov | Yaroslavl | 150003 | Russia |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| National Heart Centre Singapore | Singapore | 169609 | Singapore |
| Yonsei University Wonju Christian Hospital | Wŏnju | Gang''weondo | 26426 | South Korea |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggido | 14068 | South Korea |
| Seoul National University Hospital | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 110-746 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 3722 | South Korea |
| Gerencia de Gestion Integrada A Coruna | Department of Endocrinology and Nutrition | A Coruña | A Coruña | 15006 | Spain |
| Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial | Lugar Da Pega | A Coruña | 15405 | Spain |
| Hospital SAS de Jerez de la Frontera | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital del Mar | Nephrology Department | Barcelona | 08003 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| PTC-Primary care Trial Center | Gothenburg | 413 46 | Sweden |
| Avdelningen för kliniska prövningar AKP | Örebro | 703 62 | Sweden |
| ClinSmart | Uppsala | 752 37 | Sweden |
| Changhua Christian Hospital | Changhua | 50006 | Taiwan |
| Chang Gung Memorial Hospital Kaohsiung | Kaohsiung City | 833 | Taiwan |
| Far Eastern Memorial Hospital | Nephrology Department | New Taipei City | 220 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
| mBFAS | Modified biomarker full analysis set (mBFAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified biomarker full analysis set (mBFAS): All participants with valid informed consent for this biomarker study, which met the following criteria: a. Study enrollment criteria as defined in the study protocol. b. Analyzed biomarker samples at Visit 3 (4 months) and Visit 11 (36 months); Biomarker samples that were shipped at ambient temperatures were not analyzed. c. On Treatment at Visit 3 and Visit 11.
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| ID | Title | Description |
|---|---|---|
| BG000 | Finerenone | Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
| BG001 | Placebo | Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. |
| BG002 | 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 |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Plasma biomarker levels after 4 months of treatment | The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2^NPX) was calculated for descriptive analyses of the biomarker levels at each visit. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. | Participants in mBFAS with available data for each biomarker measurement | Geometric Mean | Standard Deviation | Linear NPX (2^NPX) |
|
| 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 | Mean Change in Plasma Biomarker Levels After 36 Months of Treatment Versus 4 Months of Treatment in a Set of 27 Pre-defined Biomarkers | The normalized protein expression (NPX) of biomarker levels were analyzed for the set of 27 pre-defined plasma biomarkers. NPX is a unit on log2-scale that is logarithmically related to protein concentration. Linear NPX (2^NPX) was calcuated for descriptive analyses of the biomarker levels at each visit. Ratios of Visit 11 (36 months of treatment) to Visit 3 (4 months of treatment) were calculated to show the change in the plasma biomarker levels. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD. Note, NPX units (Olink concentration units) are always relative units and can only be interpreted in the context of an individual study, i.e. to compare two conditions or timepoints ("change in NPX"). Equal nominal concentration values (same NPX units) for two different biomarkers measured by Olink Explore does not mean that both markers have the same absolute concentration. | Participants in mBFAS with available data for each biomarker measurement | Posted | Geometric Mean | Standard Deviation | Ratio | At 4 months (Visit 3) of treatment and 36 months (Visit 11) of treatment |
|
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|
|
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This study was a retrospective, add-on biomarker study to the multi-center, interventional Phase 3 study FIGARO-DKD (NCT02545049). There was no study-specific safety assessments in this study. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed therefore total number of participants at risk is "0" . Safety of the subjects was monitored within the FIGARO-DKD study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Finerenone | Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Placebo | Participants received matching placebo once daily in addition to standard of care therapy in previous interventional Phase 3 trial FIGARO-DKD. No new intervention was administered in this biomarker study. | 0 | 0 | 0 | 0 | 0 | 0 |
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This study was a retrospective, add-on study to the multi-center, interventional Phase 3 study FIGARO-DKD (NCT02545049). Blood plasma samples that were originally collected for PK analysis during the conduct of FIGARO-DKD study. Visit 3 (4 months of treatment) data were considered as baseline for the biomarker measurements as no pre-dose samples were available from FIGARO-DKD.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2022 | Dec 18, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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| von Willebrand factor (P04275) |
|
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| CCN family member 4 (O95388) |
|
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| Transforming growth factor beta-1 proprotein (P01137) |
|
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| Transforming growth factor beta receptor type 3 (Q03167) |
|
|
| Interleukin-15 receptor subunit alpha (Q13261) |
|
|
| Metalloproteinase inhibitor 1 (P01033) |
|
|
| Pappalysin-1 (Q13219) |
|
|
| Proto-oncogene tyrosine-protein kinase Src (P12931) |
|
|
| Protein AMBP (P02760) |
|
|
| Uromodulin (P07911) |
|
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| Aminopeptidase N (P15144) |
|
|
| Tumor necrosis factor receptor superfamily member 1A (P19438) |
|
|
| Plasminogen activator inhibitor 1 (P05121) |
|
|
| CCN family member 2 (P29279) |
|
|
| Urokinase plasminogen activator surface receptor (Q03405) |
|
|
| C-C motif chemokine 14 (Q16627) |
|
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| C-C motif chemokine 16 (O15467) |
|
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| Collagen alpha-1(I) chain (P02452) |
|
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| Decorin (P07585) |
|
|
| C-C motif chemokine 2 (P13500) |
|
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| Matrix metalloproteinase-9 (P14780) |
|
|
| E-selectin (P16581) |
|
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| Thrombospondin-2 (P35442) |
|
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| Retinoic acid receptor responder protein 2 (Q99969) |
|
|
| C-X-C motif chemokine 16 (Q9H2A7) |
|
|
| Dickkopf-related protein 3 (Q9UBP4) |
|
|
| von Willebrand factor (P04275) |
|
|
| CCN family member 4 (O95388) |
|
|
| Transforming growth factor beta-1 proprotein (P01137) |
|
|
| Transforming growth factor beta receptor type 3 (Q03167) |
|
|
| Interleukin-15 receptor subunit alpha (Q13261) |
|
|
| Metalloproteinase inhibitor 1 (P01033) |
|
|
| Pappalysin-1 (Q13219) |
|
|
| Proto-oncogene tyrosine-protein kinase Src (P12931) |
|
|
| Protein AMBP (P02760) |
|
|
| Uromodulin (P07911) |
|
|
| Aminopeptidase N (P15144) |
|
|
| Tumor necrosis factor receptor superfamily member 1A (P19438) |
|
|
| Plasminogen activator inhibitor 1 (P05121) |
|
|
| CCN family member 2 (P29279) |
|
|
| Urokinase plasminogen activator surface receptor (Q03405) |
|
|
| C-C motif chemokine 14 (Q16627) |
|
|
| C-C motif chemokine 16 (O15467) |
|
|
| Collagen alpha-1(I) chain (P02452) |
|
|
| Decorin (P07585) |
|
|
| C-C motif chemokine 2 (P13500) |
|
|
| Matrix metalloproteinase-9 (P14780) |
|
|
| E-selectin (P16581) |
|
|
| Thrombospondin-2 (P35442) |
|
|
| Retinoic acid receptor responder protein 2 (Q99969) |
|
|
| C-X-C motif chemokine 16 (Q9H2A7) |
|
|
| Dickkopf-related protein 3 (Q9UBP4) |
|
|
| The NPX difference (corresponding to log-transformed ratio to baseline) of von Willebrand factor (P04275) was analyzed. | t-test, 2 sided | = 0.002 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 4 (O95388) was analyzed. | t-test, 2 sided | = 0.044 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta-1 proprotein (P01137) was analyzed. | t-test, 2 sided | = 0.044 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta receptor type 3 (Q03167) was analyzed. | t-test, 2 sided | = 0.127 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX differences (corresponding to log-transformed ratio to baseline) of IL-15 receptor subunit alpha (Q13261) was analyzed. | t-test, 2 sided | = 0.210 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Metalloproteinase inhibitor 1 (P01033) was analyzed. | t-test, 2 sided | = 0.215 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Pappalysin-1 (Q13219) was analyzed. | t-test, 2 sided | = 0.215 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Proto-oncogene c-Src (P12931) was analyzed. | t-test, 2 sided | = 0.745 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Protein AMBP (P02760) was analyzed. | t-test, 2 sided | = 0.762 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Uromodulin (P07911) was analyzed. | t-test, 2 sided | = 0.762 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Aminopeptidase N (P15144) was analyzed. | t-test, 2 sided | = 0.762 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of TNFRSF1A (P19438) was analyzed. | t-test, 2 sided | = 0.762 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Plasminogen activator inhibitor 1 (P05121) was analyzed. | t-test, 2 sided | = 0.917 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 2 (P29279) was analyzed. | t-test, 2 sided | = 0.917 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of uPAR (Q03405) was analyzed. | t-test, 2 sided | = 0.917 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 14 (Q16627) was analyzed. | t-test, 2 sided | = 0.917 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 16 (O15467) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Collagen alpha-1(I) chain (P02452) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Decorin (P07585) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX differences (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 2 (P13500) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Matrix metalloproteinase-9 (P14780) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX differences (corresponding to log-transformed ratio to baseline) of E-selectin (P16581) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Thrombospondin-2 (P35442) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of RARRES2 (Q99969) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of C-X-C motif chemokine 16 (Q9H2A7) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |
| The NPX difference (corresponding to log-transformed ratio to baseline) of Dickkopf-related protein 3 (Q9UBP4) was analyzed. | t-test, 2 sided | = 0.979 | Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value. | Other | The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers. |