In short
Clinical trials are investigating Ambrisentan in people with pulmonary arterial hypertension and in a kidney disease study. These trials are looking at treatment effects, disease control, and patient risk measures. The studies include adults with newly diagnosed pulmonary arterial hypertension and cardiovascular comorbidities, as well as patients with chronic kidney disease.
Key points
- Clinical trials investigating Ambrisentan in the provided data focus on two very different patient groups: people with pulmonary arterial hypertension and people with chronic kidney disease. Both studies are Phase 3 trials, which means they are testing the treatment in larger patient groups. In pulmonary arterial hypertension, the study compares tadalafil plus Ambrisentan with tadalafil plus placebo in treatment-naïve patients who also have cardiovascular comorbidities. The main goal is to see how many patients reach a low or intermediate-low risk profile after 6 months. In chronic kidney disease, Ambrisentan is part of a treatment comparison that looks at change in albuminuria over 36 weeks.
Trials overview
The provided clinical trial data include two Phase 3 studies that investigate Ambrisentan in different diseases. One study is in pulmonary arterial hypertension, and the other is in chronic kidney disease. Both studies are interventional, which means the researchers assign treatments and then measure the results.
Pulmonary arterial hypertension trial
The COMMODITIES study is titled “Comparison of initial dual oral COMbination therapy to MOnotherapy in pulmonary arterial hypertension with cardiovascular comorbiDITIES.” It is an authorised Phase 3 trial with 186 planned participants. The study is looking at treatment-naïve patients with newly diagnosed pulmonary arterial hypertension and cardiovascular comorbidities.
This study compares tadalafil and Ambrisentan with tadalafil and placebo. A placebo is a look-alike treatment with no active study drug. The brief summary says the trial is designed to see how the initial treatment strategy affects disease control at 6 months.
Chronic kidney disease trial
The second study is a clinical validation study of urinary clusterin and EGF in patients with chronic kidney disease. It is a Phase 3 interventional trial with 125 planned participants, but its status is withdrawn. The intervention list includes finerenone, dapagliflozin, and Ambrisentan.
The study aims to compare a biomarker response-guided treatment approach with guideline care on albuminuria. Albuminuria means protein in the urine, which can be a sign of kidney damage. The main measurement is the change in urine albumin-to-creatinine ratio, also called UACR, from baseline to week 36.
Main endpoints and what they mean
The primary outcome in the pulmonary arterial hypertension trial is the proportion of patients who reach a low or intermediate-low risk profile after 6 months. A risk profile is a way to describe how severe the disease is and how likely it is to worsen. The study uses a non-invasive 4-risk strata method proposed by the 2022 European pulmonary hypertension guidelines.
The primary outcome in the kidney disease trial is the between-group change in albuminuria from baseline to week 36. This means the researchers compare how much protein in the urine changes between the study groups over time.
Who the trials are for
The pulmonary arterial hypertension trial is for adults who are newly diagnosed and have not yet received treatment for their disease. It also focuses on people who have cardiovascular comorbidities, meaning other heart or blood vessel conditions at the same time.
The kidney disease trial is for patients with chronic kidney disease. The data do not give more details about age limits, exact kidney stage, or other entry rules.
Trial status and enrollment
The pulmonary arterial hypertension study is marked as authorised and plans to enroll 186 patients. The chronic kidney disease study is marked as withdrawn and plans to enroll 125 patients. These status labels show the current progress of each study in the source data.