Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease
- Conditions
- Type II Diabetes Mellitus and Diabetic Kidney DiseaseMedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-000950-39-SE
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12800
- 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 < 20 pg/mL] or have had surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy.
-Subjects with type 2 diabetes mellitus as defined by the American Diabetes Association
-Subjects with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit:
Persistent high albuminuria defined as UACR of = 30 mg/g (= 3.4 mg/mmol) but < 300 mg/g (< 33.9 mg/mmol) in 2 out of 3 first morning void samples and eGFR = 25 but = 90 mL/min/1.73 m2 (CKD-EPI)
OR
Persistent very high albuminuria defined as UACR of =300 mg/g (=33.9 mg/mmol) in 2 out of 3 first morning void samples and eGFR =60 mL/min/1.73 m2 (CKD-EPI)
-Prior treatment with ACEIs and ARBs as follows:
For at least 4 weeks prior to the Run-in Visit, subjects should be treated with either an ACEI or ARB, or both
Starting with the Run-in Visit, subjects should be treated with only an ACEI or ARB
For at least 4 weeks prior to the Screening Visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
- Serum potassium = 4.8 mmol/L at both the Run-in and the Screening Visit
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7630
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5170
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method