Austell

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the extended use of TARPEYO4 (delayed-release budesonide capsules) in adults with primary IgA nephropathy who have already completed 9 months of treatment with TARPEYO4 16 mg once daily in real-world clinical practice. The study aims to determine if continuing TARPEYO4 16 mg once daily for an extended period provides additional treatment benefits, including reducing proteinuria and protecting kidney function. This is a Phase 4 clinical trial focused on assessing both the efficacy and safety of this extended treatment. The study treatment includes a 6-month period of TARPEYO4 16 mg once daily, followed by a 9-month period of TARPEYO4 8 mg once daily. After these treatment periods, participants enter a 3-month follow-up phase that includes a 2-week tapering period with TARPEYO4 4 mg once daily. The goal of this extended regimen is to maintain and improve treatment effects over a total of 2 years of TARPEYO4 therapy. Participants will be involved in the study for about 19 months. During this time, they will undergo urine tests, blood sample collections, and physical examinations to monitor their health and treatment effects. Researchers will measure the ratio of urine protein to creatinine at 6 months compared to baseline to evaluate treatment impact. Safety and kidney function will be closely observed throughout the study and follow-up periods.

Researchers are studying idiopathic pulmonary fibrosis (IPF) and other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype to understand their natural history, diagnosis, treatment, and impact on patient quality of life. This registry began enrolling patients with IPF in 2014 and expanded in 2018 to include other progressive fibrosing ILDs. The study collects detailed health information, participant-reported outcomes, blood samples, and chest imaging to support future research. Participants will be enrolled in three phases over approximately eight years across about 50 specialized centers in the United States. The original IPF cohort enrollment ended in 2018 with 1002 participants, and a new enrollment phase for up to 1000 additional IPF patients is planned for 2023–2024. Recruitment of patients with other chronic fibrosing ILDs began in 2019 and aims to include up to 1000 participants with a progressive phenotype and potentially another 1000 without it. Participants receive usual care guided by their healthcare providers while data and samples are collected. Participants will be followed for about five years for the IPF group and at least three years for the progressive fibrosing ILD group. During this time, researchers will gather clinical data, blood samples, and high-resolution chest CT scans. They will assess disease progression, healthcare use, and quality of life through questionnaires. The study also plans long-term storage of samples and images for future investigations. Safety and treatment decisions remain under the control of participants and their doctors throughout the registry.

PRIMARY OBJECTIVE: I. To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases. SECONDARY OBJECTIVES: I. To compare time to intracranial progression-free survival between FSRS and SRS. II. To compare overall survival between FSRS and SRS. III. To determine if the time to local failure is improved with FSRS compared to SRS, as evaluated by central review of imaging. IV. To evaluate if there is any difference in central nervous system (CNS) failure patterns (local versus \[vs.\] distant brain failure vs. both) in patients who receive FSRS compared to patients who receive SRS. V. To compare the rates of radiation necrosis in patients who receive FSRS vs. SRS. VI. To compare the time to salvage whole brain radiation therapy (WBRT) between patients who receive FSRS and those who receive SRS. VII. To compare the rates of post-treatment adverse events associated with FSRS and SRS. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo SRS over 30-90 minutes for 1 fraction on study. Additionally, patients undergo computed tomography (CT) and magnetic resonance imaging (MRI) on study. ARM II: Patients undergo FSRS over 30-90 minutes for 3 fractions on study. Additionally, patients undergo CT and MRI on study. After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year then every 6 months for 3 years.

Researchers are evaluating whether adding stereotactic body radiation therapy (SBRT) to the usual treatment improves outcomes for patients with locally advanced, inoperable non-small cell lung cancer that has spread to nearby tissues or lymph nodes. This phase III trial compares SBRT combined with conventional image guided radiation therapy (IGRT), chemotherapy, and immunotherapy or targeted therapy versus the usual treatment alone. The usual chemotherapy involves drugs like cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Immunotherapy with durvalumab or targeted therapy with osimertinib is also given after chemotherapy, aiming to interfere with tumor growth and spread. Patients are randomly assigned to one of two treatment groups. In the control group, patients receive conventional IGRT with weekly or every-3-week chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib. In the experimental group, patients receive SBRT to the primary tumor plus conventional IGRT to nodal metastases, combined with the same chemotherapy and consolidation therapies as the control group. Radiation therapies are delivered with precision to minimize damage to healthy tissue. Follow-up imaging with CT and/or PET/CT scans are performed during and after treatment. Participants undergo physical exams, imaging scans, pulmonary function tests, and quality of life assessments before, during, and after treatment. Researchers monitor overall survival and progression-free survival for up to eight years. They also track tumor response, local control, treatment side effects, lung function changes, and patient-reported outcomes. Follow-up visits occur every three months for one year, every six months for years two and three, and yearly thereafter to assess long-term effects and safety.