A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.

• Status: Withdrawn
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to the background antihypertensive therapy in patients with uncontrolled blood pressure and chronic kidney disease (CKD) stage 3 or 4. Participation in the research study will last up to 21 weeks (about 5 months).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.
• Collaborator: Janssen Biotech, Inc.

Criteria

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.