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WithdrawnNCT04162366INSPIRE-CKDUpdated Nov 23, 2022

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

A Phase 3 interventional study of Aprocitentan 25 mg and Placebo in Hypertension and Renal Insufficiency, Chronic, sponsored by Idorsia Pharmaceuticals Ltd.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-23.

Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 3, Interventional, and Treatment

Why this study was withdrawn
A business decision was made to not initiate this study
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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).

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Conditions studied

  • Hypertension
  • Renal Insufficiency, Chronic

Keywords

  • Chronic kidney disease
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

Browse Kidney Diseases studies →

Lead sponsor

Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Aprocitentan 25 mg

    Drug: Aprocitentan 25 mg

  • Experimental
    Placebo

    Drug: Placebo

  • Experimental
    Aprocitentan 25 mg or Placebo

    Drug: Aprocitentan 25 mg · Drug: Placebo

Interventions

  • DrugAprocitentan 25 mg

    Tablet, oral use once daily

    Also known as: ACT-132577

  • DrugPlacebo

    Matching placebo tablet, oral use once daily

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

    Time frame: From baseline to Week 4 after treatment initiation

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04162366
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Collaborators
Janssen Biotech, Inc.
Responsible party
Sponsor
First posted
Nov 14, 2019
Start date
Jan 2020 (estimated)
Primary completion
Jun 30, 2021 (estimated)
Completion
Jul 15, 2021 (estimated)
Last update
Nov 23, 2022

Study contacts

Clinical Trials
study director · Idorsia Pharmaceuticals Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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