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

Phase 3

Withdrawn

• Conditions: Hypertension; Renal Insufficiency, Chronic
• Interventions: Drug: Aprocitentan 25 mg; Drug: Placebo

• Registration Number: NCT04162366
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Study Start: 2020-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aprocitentan 25 mg	Aprocitentan 25 mg	-
Placebo	Placebo	-
Aprocitentan 25 mg or Placebo	Aprocitentan 25 mg	-
Aprocitentan 25 mg or Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.	From baseline to Week 4 after treatment initiation

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.	From baseline to Week 4 after treatment initiation
Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4	From baseline to Week 4 after treatment initiation	Evaluated in the subgroup of participants with a UACR greater than 30 mg/g at baseline.