A research study to find out if aprocitentan is efficacious and safe to treat patients with uncontrolled blood pressure and chronic kidney disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Screening Visit:
- Signed and dated informed consent prior to any study-mandated procedure,
- Adult male and female subjects,
- Prior treatment with at least 2 anti-hypertensive medications, at optimal or best tolerated dose, of different pharmacological classes, including a diuretic,
- Subjects 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, eGFR, of at least 15 and below 60 mL/min/1.73m2 using the Chronic Kidney Disease-Epidemiology (CKD-EPI)
equation.),
- Women of childbearing potential (WOCBP) 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 as described up to at least 30 days after randomized study treatment discontinuation.

Run-in period criteria:
- Mean trough sitting systolic blood pressure of 140 mmHg or higher measured by automated office blood pressure measurement (AOBPM).

Randomization (Baseline) criteria (end of the 2 week run-in period):
- Mean trough sitting systolic blood pressure of 140 mmHg or higher measured by AOBPM,
- Stable background anti-hypertensive therapy (including a diuretic) since the start of the run-in period,
- Estimated glomerular filtration rate (eGFR) equal or above 15 to less than 60 mL/min/1.73 m2,
- Subject is at least 80% compliant with study treatment (tablet count) during the run-in period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

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 more 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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