A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

CompletadoFase 3ClinicalTrials.gov

ID: NCT02545049Tipo: INTERVENTIONALInicio: 17 de sept de 2015Fin estimado: 2 de feb de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men or women ≥18 years of age
Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
Serum potassium \<=4.8 mmol/L

Criterios de exclusión

Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)
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 \[class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)\]
Dialysis for acute renal failure within 12 weeks of Run-in visit
Renal allograft in place or scheduled kidney transplant within next 12 months
Glycated hemoglobin (HbA1c) \>12%

Intervenciones

drug

Finerenone (BAY94-8862)

10 mg or 20 mg Finerenone tablet to be given orally, once daily.

drug

Placebo

Matching placebo to be taken orally, once daily.

Ubicaciones

CABA, Buenos Aires, Argentina

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

Patrocinadores

PrincipalBayer

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