Clinical trial NCT04162366: A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
Official title: Multi-center, Blinded, Randomized Study With Aprocitentan in Subjects With Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension
Renal Insufficiency, Chronic
Keywords: Chronic kidney disease
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Janssen Biotech, Inc.
First posted: 2019-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will get the active drug, aprocitentan 25 mg, for at least 8 weeks. All participants will receive placebo for 2 weeks. During a certain period of the study, participants will receive aprocitentan 25 mg or placebo for 4 weeks.
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.
timeFrame: From baseline to Week 4 after treatment initiation
Secondary outcomes:
measure: Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.
timeFrame: From baseline to Week 4 after treatment initiation
measure: Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4
timeFrame: From baseline to Week 4 after treatment initiation
Other outcomes:
Locations:
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References: