INSPIRE-CKDAprocitentan for Uncontrolled Blood Pressure and Chronic Kidney Disease Stage 3 or 4
This study aims to evaluate the effectiveness of Aprocitentan in reducing uncontrolled blood pressure in individuals with Chronic Kidney Disease Stage 3 or 4, by measuring changes in sitting systolic blood pressure from the start to the fourth week of treatment.
Aprocitentan 25 mg
+ Placebo
Urogenital Diseases+12
+ Cardiovascular Diseases
+ Chronic Disease
Treatment Study
Summary
Study start date: January 1, 2020
Actual date on which the first participant was enrolled.This research study aims to test the effectiveness of a new drug called aprocitentan in lowering blood pressure. The study focuses on individuals who have uncontrolled blood pressure and are in the stage 3 or 4 of chronic kidney disease (CKD). The goal is to see if adding aprocitentan to their current blood pressure medications can help control their blood pressure better. This is important because managing blood pressure is crucial for people with CKD, as it can help slow down the progression of the disease and improve overall health. The study lasts for about 5 months. During this time, participants will receive aprocitentan in addition to their usual blood pressure medications. The main measurement of the study is the change in sitting blood pressure from the start to the fourth week of the treatment. This will be measured using an automated office blood pressure machine. The study is designed to understand if aprocitentan can help lower blood pressure when added to existing treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives