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

Idorsia Pharmaceuticals

Status and phase: Withdrawn; Phase 3

Conditions: Hypertension; Renal Insufficiency, Chronic

Treatments: Drug: Aprocitentan 25 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04162366

2018-003819-22 (EudraCT Number)

ID-080A305

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Aprocitentan 25 mg

Experimental group

Treatment:

Drug: Aprocitentan 25 mg

Placebo

Experimental group

Treatment:

Drug: Placebo

Aprocitentan 25 mg or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: Aprocitentan 25 mg