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

Last updated: November 22, 2022
Sponsor: Idorsia Pharmaceuticals Ltd.
Overall Status: Trial Not Available

Phase

3

Condition

Nephropathy

Williams Syndrome

Renal Failure

Treatment

N/A

Clinical Study ID

NCT04162366
ID-080A305
2018-003819-22
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prior treatment with at least 2 anti-hypertensive medications, at optimal or besttolerated 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 GlomerularFiltration Rate of at least 15 and below 60 mL/min/1.73m2 using the Chronic KidneyDisease-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 ofrun-in period).
  • Agree to undertake pregnancy tests during the study and up to 30 days afterrandomized study treatment discontinuation.
  • Agree to use highly-effective methods of contraception up to at least 30 daysafter study treatment discontinuation.

Exclusion

Exclusion Criteria:

  • Mean sitting systolic blood pressure above 170 mmHg measured by "automated officeblood pressure measurement" (AOBPM),
  • Mean sitting diastolic blood pressure above 105 mmHg measured by AOBPM,
  • Change in renal function requiring hospitalization, documented eGFR decline of greaterthan 20% in the 3 months prior to the screening visit, dialysis in the 3 months beforethe 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 Start date:
January 01, 2020
Estimated Completion Date:
July 15, 2021