Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Finerenone (BAY94-8862); Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 823.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was
      safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy.
      These treatment doses were compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and 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 and if they agree to use adequate contraception when sexually active.

          -  Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

               -  are on oral antidiabetics and / or insulin,

               -  have a documented fasting glucose >/= 7.0 mmol/L in the medical history,

               -  have a 2 hour plasma glucose >/=11.1 mmol/L during an oral glucose tolerance test
                  in the medical history, or

               -  have a glycated hemoglobin (HbA1c) >/=6.5% [National Glycohemoglobin
                  Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)]
                  in the medical history or at the run-in visit

          -  Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of
             the following criteria:

               -  Persistent very high albuminuria defined as urinary albumin-to-creatine ratio
                  (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 < 90
                  mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL =
                  milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or

               -  Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g in
                  (>/=3.4mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR
                  >/=30 mL/min/1.73 m² but < 90 mL/min/1.73m²

          -  Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or
             angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to
             this therapy for at least 4 weeks prior to the screening visit

          -  Serum potassium </= 4.8 mmol/L at both the run-in visit and the screening visit

        Exclusion Criteria:

          -  Non-diabetic renal disease

          -  Glycated hemoglobin (HbA1c) >12% at the run-in visit or the screening visit

          -  UACR >3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the
             run-in visit or screening visit

          -  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 supine
             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

          -  Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or
             potassium-sparing diuretic

          -  Dialysis for acute renal failure within the previous 6 months prior to the run-in
             visit