INSPIRE-CKDAprocitentan para hipertensión arterial no controlada y enfermedad renal crónica en etapa 3 o 4

Fecha de inicio: 1 de enero de 2020

Inclusion Criteria: * Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic, * Participants with uncontrolled blood pressure (mean sitting systolic blood pressure of 140 mmHg or greater) and chronic kidney disease stage 3 or 4 (estimated Glomerular Filtration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology equation), * Women of childbearing potential are eligible only if the following applies: * Negative pregnancy test at the screening visit and at baseline (i.e., end of run-in period). * Agree to undertake pregnancy tests during the study and up to 30 days after randomized study treatment discontinuation. * Agree to use highly-effective methods of contraception up to at least 30 days after study treatment discontinuation. Exclusion Criteria: * Mean sitting systolic blood pressure above 170 mmHg measured by "automated office blood pressure measurement" (AOBPM), * Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM, * Change in renal function requiring hospitalization, documented eGFR decline of greater than 20% in the 3 months prior to the screening visit, dialysis in the 3 months before the screening visit, * Planned dialysis or kidney transplant during the course of this study, * Nephrotic syndrome defined as urine albumin-to-creatinine ratio above 3000 mg/g, * Known and documented chronic heart failure.