Back to resultsA Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease. (INSPIRE-CKD)
Primary Purpose
Hypertension, Renal Insufficiency, Chronic
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Aprocitentan 25 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Chronic kidney disease
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Aprocitentan 25 mg
Placebo
Aprocitentan 25 mg or Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.
Secondary Outcome Measures
Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.
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.
Full Information
NCT ID
NCT04162366
First Posted
November 11, 2019
Last Updated
November 22, 2022
Sponsor
Idorsia Pharmaceuticals Ltd.
Collaborators
Janssen Biotech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04162366
Brief Title
A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
A business decision was made to not initiate this study
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
July 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.
Collaborators
Janssen Biotech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Renal Insufficiency, Chronic
Keywords
Chronic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aprocitentan 25 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Arm Title
Aprocitentan 25 mg or Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aprocitentan 25 mg
Other Intervention Name(s)
ACT-132577
Intervention Description
Tablet, oral use once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet, oral use once daily
Primary Outcome Measure Information:
Title
Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.
Time Frame
From baseline to Week 4 after treatment initiation
Secondary Outcome Measure Information:
Title
Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.
Time Frame
From baseline to Week 4 after treatment initiation
Title
Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4
Description
Evaluated in the subgroup of participants with a UACR greater than 30 mg/g at baseline.
Time Frame
From baseline to Week 4 after treatment initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Idorsia Pharmaceuticals Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
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