Type II Diabetes Mellitus and Diabetic Kidney Disease MedDRA version: 21.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men or women aged 18 years and older. The lower age limit may be higher if legally required in the participating country. - Women of childbearing potential can only be included in the study if a pregnancy test is negative at the screening visit and if they agree to use adequate contraception. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate) or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL [for US only: FSH levels > 40 mIU/mL and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range 5170
Exclusion criteria
Exclusion criteria: - Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis - Uncontrolled arterial hypertension with mean sitting systolic blood pressure (SBP) = 170 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 - Clinical diagnosis of chronic HFrEF and persistent symptoms (NYHA class II – IV) at Run in visit (class 1A recommendation for MRAs) - Dialysis for acute renal failure within 12 weeks of Run-in visit - Renal allograft in place or scheduled kidney transplant within next 12 months from the Run-in visit - HbA1c > 12% (> 108 mmol/mol) at the Run-in Visit or Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the time to first occurrence of cardiovascular mortality and morbidity in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease. ;Secondary Objective: •Delays the time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) of =40% from baseline over at least 4 weeks or renal death •Delays the time to all-cause hospitalization •Delays the time to all-cause mortality •Change in UACR from baseline to Month 4 •Delays the time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in eGFR of =57% from baseline over at least 4 weeks or renal death. ;Primary end point(s): Time to first occurrence of the composite endpoint of CV death or non-fatal CV event (i.e. myocardial infarction, stroke, or hospitalization for HF).;Timepoint(s) of evaluation of this end point: From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: For all endpoints: From randomization (Visit 1) until the end of study following the study termination decision, approximately from 18 to 36 months Except endpoint*: Frombaseline / randomization to Month 4;Secondary end point(s): Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease of eGFR = 40% from baseline over at least 4 weeks or renal death Time to all-cause hospitalization Time to all-cause mortality Change in UACR from baseline to Month 4 Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in eGFR of = 57% from baseline over at least 4 weeks or renal death. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed