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

Hypertension Clinical Trial

— INSPIRE-CKD  

Official title:

Multi-center, Blinded, Randomized Study With Aprocitentan in Subjects With Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04162366
• Other study ID #: ID-080A305
• Secondary ID: 2018-003819-22
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: November 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 15, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Aprocitentan 25 mg
Tablet, oral use once daily
• Placebo
Matching placebo tablet, oral use once daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4	Evaluated in the subgroup of participants with a UACR greater than 30 mg/g at baseline.	From baseline to Week 4 after treatment initiation