Resumen

El objetivo principal de este estudio fue demostrar si, además del tratamiento estándar, finerenone es superior al placebo en retrasar la progresión de la enfermedad renal, medido por el criterio de valoración compuesto de tiempo hasta la primera aparición de insuficiencia renal, una disminución sostenida de la tasa de filtración glomerular estimada (TFGe) ≥40% desde el valor basal durante al menos 4 semanas, o muerte de causa renal.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men or women ≥18 years of age
Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:
persistent high albuminuria (UACR ≥30 to \<300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) ≥25 but \<60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
persistent very high albuminuria (UACR ≥300 mg/g in 2 out of 3 first morning void samples) and eGFR ≥25 to \<75 mL/min/1.73 m² (CKD-EPI)
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

Criterios de exclusión

Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run-in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
Glycated hemoglobin (HbA1c) \>12%
Mean SBP \< 90 mmHg at the run-in visit or at the screening visit
Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association \[NYHA\] class II - IV) at run-in visit (class 1A recommendation for mineralcorticoid receptor antagonists \[MRAs\])
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 of run-in visit
Renal allograft in place or scheduled within next 12 months from the run-in visit

Intervenciones

drug

Finerenone (BAY94-8862)

Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to \< 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR ≥ 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

drug

Placebo

Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

Ubicaciones

Junín, Buenos Aires, Argentina

Lanús, Buenos Aires, Argentina

Mar del Plata, Buenos Aires, Argentina

Sarandí, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

CABA, Ciudad Auton. de Buenos Aires, Argentina

Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Córdoba, Argentina

San Luis, Argentina