Clareo Health | A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Idorsia Pharmaceuticals Ltd.
With
Janssen Biotech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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,
