Table of Contents
- Trials overview
- Pulmonary arterial hypertension trial
- Chronic kidney disease trial
- Main endpoints and what they mean
- Who the trials are for
- Trial status and enrollment
Trials overview
The provided clinical trial data include two Phase 3 studies that investigate Ambrisentan in different diseases.[1][2] One study is in pulmonary arterial hypertension, and the other is in chronic kidney disease.[1][2] Both studies are interventional, which means the researchers assign treatments and then measure the results.[1][2]
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.”[1] It is an authorised Phase 3 trial with 186 planned participants.[1] The study is looking at treatment-naïve patients with newly diagnosed pulmonary arterial hypertension and cardiovascular comorbidities.[1]
This study compares tadalafil and Ambrisentan with tadalafil and placebo.[1] A placebo is a look-alike treatment with no active study drug.[1] The brief summary says the trial is designed to see how the initial treatment strategy affects disease control at 6 months.[1]
Chronic kidney disease trial
The second study is a clinical validation study of urinary clusterin and EGF in patients with chronic kidney disease.[2] It is a Phase 3 interventional trial with 125 planned participants, but its status is withdrawn.[2] The intervention list includes finerenone, dapagliflozin, and Ambrisentan.[2]
The study aims to compare a biomarker response-guided treatment approach with guideline care on albuminuria.[2] Albuminuria means protein in the urine, which can be a sign of kidney damage.[2] The main measurement is the change in urine albumin-to-creatinine ratio, also called UACR, from baseline to week 36.[2]
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.[1] A risk profile is a way to describe how severe the disease is and how likely it is to worsen.[1] The study uses a non-invasive 4-risk strata method proposed by the 2022 European pulmonary hypertension guidelines.[1]
The primary outcome in the kidney disease trial is the between-group change in albuminuria from baseline to week 36.[2] This means the researchers compare how much protein in the urine changes between the study groups over time.[2]
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.[1] It also focuses on people who have cardiovascular comorbidities, meaning other heart or blood vessel conditions at the same time.[1]
The kidney disease trial is for patients with chronic kidney disease.[2] The data do not give more details about age limits, exact kidney stage, or other entry rules.[2]
Trial status and enrollment
The pulmonary arterial hypertension study is marked as authorised and plans to enroll 186 patients.[1] The chronic kidney disease study is marked as withdrawn and plans to enroll 125 patients.[2] These status labels show the current progress of each study in the source data.[1][2]
