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

NCT04162366 | Withdrawn Phase 3 DMC FDA Drug

• 2 other identifiers: ID-080A3052018-003819-22
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Hypertension; Renal Insufficiency, Chronic

Keywords

Chronic kidney disease

Outcome Measures

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.

  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.

  From baseline to Week 4 after treatment initiation

• Ratio to baseline of urine albumin-to-creatinine ratio (UACR) at Week 4

  From baseline to Week 4 after treatment initiation

Study Arms (3)

Aprocitentan 25 mg

EXPERIMENTAL

Drug: Aprocitentan 25 mg

Placebo

EXPERIMENTAL

Drug: Placebo

Aprocitentan 25 mg or Placebo

EXPERIMENTAL

Drug: Aprocitentan 25 mg; Drug: Placebo

Interventions

Aprocitentan 25 mg DRUG

Tablet, oral use once daily

Also known as: ACT-132577

Aprocitentan 25 mg; Aprocitentan 25 mg or Placebo

Placebo DRUG

Matching placebo tablet, oral use once daily

Aprocitentan 25 mg or Placebo; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead
• Janssen Biotech, Inc.: collaborator

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Interventions

aprocitentan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: January 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 15, 2021
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share