An Observational Study Called FLAMINgO to Learn More About the Treatment Combination of Finerenone and SGLT2 Inhibitors in People With Long-term Kidney Disease (Chronic Kidney Disease) Together With Type 2 Diabetes by Using Routine Medical Care Data and Past Clinical Study Results

Launched by BAYER · Dec 6, 2022

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Eligibility criteria

• Inclusion Criteria:
• • FIDELIO-DKD patients: Participants with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit: Persistent high albuminuria or Persistent very high albuminuria.
• • FIGARO-DKD patients: Participants with a clinical diagnosis of DKD based on either of the following criteria at the Run-in and Screening Visit: Persistent high albuminuria or Persistent very high albuminuria.
• • Men or women aged 18 years and older
• • 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.
• • Diagnosed with type 2 diabetes.
• * Prior treatment with Angiotensin-converting-enzyme inhibitors (ACEIs) and Angiotensin receptor blockers (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.
• • SGLT2 inhibitor use at baseline: Canagliflozin, Dapagliflozin, Empagliflozin, Ertugliflozin, Ipragliflozin, Luseogliflozin, Tofogliflozin.
• Exclusion Criteria:
• • Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis.
• • Urine Albumin-Creatinine Ratio (UACR) \>5000 mg/g (\>565 mg/mmol) at the Run-in Visit or Screening Visit.
• • Hemoglobin A1C (HbA1c) \> 12% (\> 108 mmol/mol) at the Run-in Visit or Screening Visit.
• • 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.
• • Mean SBP \< 90 mmHg at the Run-in Visit or at the Screening Visit.
• • Subjects with a clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II - IV) at the Run-in Visit (class 1A recommendation for MRAs).
• • Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the Screening Visit.
• • Dialysis for acute renal failure within 12 weeks prior to the Run-in Visit.
• • Renal allograft in place or a scheduled kidney transplant within the next 12 months from the Run-in Visit.
• • Addison's disease.
• • Hepatic insufficiency classified as Child-Pugh C.
• • Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic which cannot be discontinued at least 4 weeks prior to the Screening Visit.
• • Concomitant therapy with both ACEI and ARBs which cannot be discontinued for the purpose of the study.
• • Concomitant therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers (to be stopped at least 7 days before randomization).