Diabetic nephropathy MedDRA version: 16.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: BAY 94-8862 IR tablet 1.25 mg
Product Code: BAY 94-8862 coated tablet 1.25 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Finerenone
CAS Number: 1050477-31-0
Current Spo
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women aged 18 years and older. - Subjects with type 2 diabetes mellitus - Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria: Persistent very high albuminuria defined as UACR of >= 300 mg/g (>=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >=30 mL/min/1.73 m2 but =30 mg/g but =3.4 mg/mmol but =30 mL/min/1.73 m2 but =65 years) yes F.1.3.1 Number of subjects for this age range 670
Exclusion criteria
Exclusion criteria: Non-diabetic renal disease (confirmed by biopsy) Known bilateral clinically relevant renal artery stenosis (>75%) Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean sitting SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the run-in visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Ratio of urinary-albumin-to-creatinine-ratio (UACR) at Visit 5 (Day 90 +/- 2) to UACR at baseline;Timepoint(s) of evaluation of this end point: 90 days;Main Objective: Primary objective of the study is to investigate the change of urinary albumin-to-creatinine ratio (UACR) after treatment with different oral doses of BAY 94 8862 given once daily over 90 days;Secondary Objective: Change in serum potassium Change in renal function Change in health related quality of life Number of participants with adverse events as a measure of safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in serum potassium Change in renal function Change in health related quality of life Number of participants with adverse events as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: From baseline to 90 days From baseline to 90 days From baseline to 90 days Up to 120 days | — |
Countries
Australia, Austria, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, Taiwan, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed