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This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design.
Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY94-8862 (1.25 mg) | Experimental |
| |
| BAY94-8862 (2.5 mg) | Experimental |
| |
| BAY94-8862 (5 mg ) | Experimental |
| |
| BAY94-8862 (7.5 mg) | Experimental |
| |
| BAY94-8862 (10 mg) | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| BAY 94-8862 (15 mg) | Experimental |
| |
| BAY 94-8862 (20 mg) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY94-8862 | Drug | 1.25 mg BAY94-8862 tablet once daily in the morning |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of urinary albumin-to creatinine ratio | Baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum potassium concentration | Baseline and 90 days |
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Inclusion Criteria:
Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB)
Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria:
Serum potassium </=4.8 mmol/L at both the run-in visit and the screening visit
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 456-0058 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38537621 | Derived | Li P, Cui Y, Xu X, Dong J, Liao L. Cardiorenal Benefits of Finerenone in Different Races and Kidney Function in Patients with Chronic Kidney Disease. Cardiorenal Med. 2024;14(1):227-234. doi: 10.1159/000538347. Epub 2024 Mar 27. | |
| 31583611 | Derived | Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x. |
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|
| BAY94-8862 |
| Drug |
2.5 mg BAY94-8862 tablet once daily in the morning |
|
| BAY94-8862 | Drug | 5 mg BAY94-8862 tablet once daily in the morning |
|
| BAY94-8862 | Drug | 7.5 mg BAY94-8862 tablet once daily in the morning |
|
| BAY94-8862 | Drug | 10 mg BAY94-8862 tablet once daily in the morning |
|
| Placebo | Drug | Placebo tablet once daily in the morning |
|
| BAY 94-8862 | Drug | 15 mg BAY 94-8862 tablet once daily in the morning |
|
| BAY 94-8862 | Drug | 20 mg BAY 94-8862 tablet once daily in the morning |
|
| Nagoya |
| Aichi-ken |
| 466-0815 |
| Japan |
| Saijō | Ehime | 793-0027 | Japan |
| Kurume | Fukuoka | 830-8522 | Japan |
| Kurume | Fukuoka | 830-8543 | Japan |
| Obihiro | Hokkaido | 080-0848 | Japan |
| Amagasaki | Hyōgo | 660-8550 | Japan |
| Koga | Ibaraki | 306-0232 | Japan |
| Tsuchiura | Ibaraki | 300-0835 | Japan |
| Tsukuba | Ibaraki | 305-0812 | Japan |
| Kahoku-gun | Ishikawa-ken | 920-0293 | Japan |
| Sakaidechō | Kagawa-ken | 762-0007 | Japan |
| Izumisano | Osaka | 598-8577 | Japan |
| Yao | Osaka | 581-0011 | Japan |
| Katsushika-ku | Tokyo | 125-0054 | Japan |
| Osaka | 530-0001 | Japan |
| 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 |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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