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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000656-26 | EudraCT Number |
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The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fulacimstat (BAY1142524) | Experimental | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
|
| Placebo | Placebo Comparator | Patients have to have a clinical diagnosis of diabetic kidney disease and have to be treated with standard of care for this condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulacimstat (BAY1142524) | Drug | 25 mg BAY1142524 are given twice daily over a treatment period of 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary albumin to creatinine ratio (UACR) | The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment | Baseline and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment-emergent adverse event | From first intake of study drug up to 3 days after last administration of study drug | |
| Number of patients with serious adverse events | From first intake of study drug up to 3 days after last administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Med Centre Diamedical 2013 | Dimitrovgrad | 6400 | Bulgaria | |||
| MCOMH Preventsia-2000 |
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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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| Placebo | Drug | Matching placebo tablets are given twice daily over a treatment period of 6 months |
|
| Stara Zagora |
| 6000 |
| Bulgaria |
| Med. Center Equita | Varna | 9000 | Bulgaria |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Steno Diabetes Center Copenhagen | Gentofte Municipality | 2730 | Denmark |
| Nordsjællands Hospital | Hillerød | 3400 | Denmark |
| Pihlajalinna ITE Kuopio | Kuopio | 70100 | Finland |
| Terveystalo Oulu | Oulu | FI-90100 | Finland |
| TAYS TKI Keskus Tutkimusvastaanotto | Tampere | 33520 | Finland |
| Turun yliopistollinen keskussairaala, kantasairaala | Turku | FIN-20520 | Finland |
| Barzilai Medical Center | Ashkelon | 7830604 | Israel |
| Edith Wolfson Medical Center | Holon | 5822012 | Israel |
| Hadassah Hebrew University Hospital Ein Kerem | Jerusalem | 9112001 | Israel |
| The Nazareth Trust Hospital EMMS | Nazareth | 16100 | Israel |
| DMC - Diabetes Medical Center | Tel Aviv | 6937947 | Israel |
| Shamir Medical Center (Assaf Harofeh) | Ẕerifin | 7030000 | Israel |
| IRCCS Casa Sollievo della Sofferenza | Foggia | Apulia | 71013 | Italy |
| A.O.U. Policlinico Federico II Napoli | Naples | Campania | 80131 | Italy |
| Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim | Bologna | Emilia-Romagna | 40138 | Italy |
| A.O.U. di Padova | Padova | Veneto | 35128 | Italy |
| Complexo Hospitalario Universitario de Ferrol | Ferrol | A Coruña | 15405 | Spain |
| Hospital de Galdakao | Galdakao | Vizcaya | 48960 | Spain |
| Hospital Fundació Puigvert | Barcelona | 08025 | Spain |
| Centralsjukhuset Kristianstad | Kristianstad | 29185 | Sweden |
| Universitetssjukhuset Örebro | Örebro | 701 85 | Sweden |
| Akardo MedSite AB | Stockholm | 114 46 | Sweden |
| S3 Clinical Research Centers | Vällingby | 162 68 | Sweden |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000709182 | fulacimstat |
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