HypertensionPhase 3INSPIRE-CKDNCT04162366
A Research Study to Show Aprocitentan is Efficacious and Safe to Treat Patients With Uncontrolled Blood Pressure and Chronic Kidney Disease.
A Phase 3 study testing Aprocitentan 25 mg in people with Hypertension and Renal Insufficiency, Chronic, run by Idorsia Pharmaceuticals Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Renal Insufficiency, Chronic
- What is being tested?
- Aprocitentan 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to 15 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Multi-center, Blinded, Randomized Study With Aprocitentan in Subjects With Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4.
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).
- Conditions
- Hypertension, Renal Insufficiency, Chronic
- Being tested
- Aprocitentan 25 mg, Placebo
- Keywords
- Chronic kidney disease
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprocitentan 25 mgDrug
Also called ACT-132577
Tablet, oral use once daily
PlaceboDrug
Matching placebo tablet, oral use once daily
| Study group | Role | What they receive |
|---|---|---|
| Aprocitentan 25 mg | Experimental | Not described Receives: Drug: Aprocitentan 25 mg |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
| Aprocitentan 25 mg or Placebo | Experimental | Not described Receives: Drug: Aprocitentan 25 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 4 of double-blind treatment in mean trough sitting systolic blood pressure measured by automated office blood pressure measurement.
Measured: From baseline to Week 4 after treatment initiation
Secondary outcomes (2)
Change from baseline to Week 4 of double-blind treatment in mean trough sitting diastolic blood pressure measured by automated office blood pressure measurement.
Measured: From baseline to Week 4 after treatment initiation
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.
Measured: From baseline to Week 4 after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study startJan 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Why it stopped: A business decision was made to not initiate this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162366
- Sponsor's protocol ID
- ID-080A305
- Other IDs
- 2018-003819-22, 2018
- Acronym
- INSPIRE-CKD
- Status last verified
- Nov 2022
- First submitted
- 11 Nov 2019
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Blinded, Randomized Study With Aprocitentan in Subjects With Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4.
- ClinicalTrials.gov ID
- NCT04162366
- Acronym / sponsor ID
- INSPIRE-CKD / ID-080A305
- Conditions
- Hypertension, Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A business decision was made to not initiate this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Janssen Biotech, Inc.
- Study start
- Jan 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aprocitentan 25 mg | Experimental | Drug: Aprocitentan 25 mg |
| Placebo | Experimental | Drug: Placebo |
| Aprocitentan 25 mg or Placebo | Experimental | Drug: Aprocitentan 25 mg, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aprocitentan 25 mgAlso: ACT-132577Tablet, oral use once daily | Drug | Aprocitentan 25 mg, Aprocitentan 25 mg or Placebo |
| PlaceboMatching placebo tablet, oral use once daily | Drug | Aprocitentan 25 mg or Placebo, Placebo |
Primary outcome
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
2 secondary outcomes
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
Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4
Time frame: From baseline to Week 4 after treatment initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aprocitentan 25 mg in people with Hypertension and Renal Insufficiency, Chronic, run by Idorsia Pharmaceuticals Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From baseline to Week 4 after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.