Austell

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating real-world treatment patterns, effectiveness, and side effects of xanomeline and trospium chloride KarXT in adults diagnosed with schizophrenia in the United States. The study aims to understand how these medications are used and their impact on patients, including treatment switches and titration over time. Participants diagnosed with schizophrenia who have started treatment with KarXT will be observed according to the product label for up to 20 weeks. The study includes those newly starting KarXT or switching from other antipsychotic treatments, with data collected on dosing changes, adverse events, symptom improvement, and treatment continuation. During the study, participants will undergo regular clinical assessments, including monitoring of weight, psychiatric symptoms using the Clinical Global Impressions - Improvement score, and recording any schizophrenia-related relapses or hospital visits. Researchers will track medication adherence, reasons for stopping treatment, and use of antiemetic medications for gastrointestinal symptoms, with baseline and follow-up data collected up to 20 weeks.

This trial focuses on adults with primary IgA nephropathy IgAN who have already completed 9 months of treatment with TARPEYO4 delayed-release budesonide capsules at 16 mg once daily in regular clinical practice. The study aims to determine if continuing TARPEYO4 treatment provides further benefits in reducing proteinuria and protecting kidney function over a longer period. This is a phase 4, open-label study sponsored by Calliditas Therapeutics AB. Participants will undergo an extended treatment regimen lasting about 15 months, starting with 6 months of TARPEYO4 16 mg once daily, followed by 9 months of TARPEYO4 8 mg once daily. After this, there will be a 3-month follow-up period, including a 2-week tapering phase with TARPEYO4 4 mg once daily. The goal is to maintain or improve treatment effects while reducing dosage gradually. During the study, participants will have urine tests, blood samples, and physical exams at regular intervals to monitor kidney function and protein levels. Researchers will measure the urine protein to creatinine ratio UPCR and estimated glomerular filtration rate eGFR at various points, assessing safety by tracking adverse events over approximately 19 months. The study includes thorough follow-up to evaluate the ongoing impact of extended TARPEYO4 use.

Researchers are studying Idiopathic Pulmonary Fibrosis IPF and other chronic fibrosing interstitial lung diseases ILDs with a progressive phenotype through the IPF-PRO and ILD-PRO Registries. This prospective registry collects data on the natural history, healthcare experiences, quality of life, and treatments of participants diagnosed with IPF or other chronic fibrosing ILDs. Blood samples and chest imaging studies are also gathered and stored for future research. The registry originally enrolled over 1000 participants with IPF and expanded to include other fibrosing ILDs with progressive phenotypes, aiming to enroll up to 1000 additional patients in each phase.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are comparing two types of radiation therapy, fractionated stereotactic radiosurgery FSRS and the usual stereotactic radiosurgery SRS, in treating patients whose cancer has spread to the brain from other parts of the body. This phase III study aims to see if FSRS, which delivers radiation over three sessions, improves the time before the tumor returns compared to SRS, which delivers a single high-dose radiation treatment. The study also looks at other outcomes such as overall survival, brain progression, and side effects of the treatments. Participants are randomly assigned to one of two groups. One group receives a single session of SRS lasting 30 to 90 minutes, while the other group receives FSRS divided into three sessions of the same length. Both groups undergo computed tomography CT and magnetic resonance imaging MRI scans during the study. After treatment, patients are followed closely with regular check-ups every three months for the first year, then every four months for the second year, and every six months for the following three years. During the study, participants will have imaging scans to monitor tumor response and progression. Researchers will measure how long it takes for the tumor to grow back, progression of cancer in the brain, overall survival, and any radiation-related side effects. Safety is monitored for up to two years, and tumor outcomes are tracked for up to five years. This thorough follow-up helps to understand the long-term effects of the two radiation methods in patients with brain metastases.

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 NSCLC that has spread to nearby tissues or lymph nodes. This phase III trial compares the effect of SBRT combined with conventional image guided radiation therapy IGRT, chemotherapy, and immunotherapy or targeted therapy against the usual treatment alone. The study aims to assess overall survival, progression-free survival, tumor response, lung function, quality of life, and treatment-related side effects. Participants are randomly assigned to one of two groups. In the first group, patients receive conventional IGRT and chemotherapy with drugs such as paclitaxel, carboplatin, pemetrexed, cisplatin, or etoposide during radiation, followed by immunotherapy with durvalumab or targeted therapy with osimertinib. The second group receives SBRT combined with conventional IGRT and similar chemotherapy, followed by the same immunotherapy or targeted therapy options. Both groups undergo CT andor PETCT scans during follow-up. Chemotherapy schedules vary by drug, including weekly or every 21-day dosing during radiotherapy, with consolidation treatments lasting up to one year. Throughout the study, participants undergo assessments including lung function tests FEV1 and DLCO, quality of life questionnaires, imaging scans, and monitoring for side effects using standard criteria. Follow-up visits occur every three months for the first year, every six months during years two and three, and annually thereafter, continuing for the duration of the study. Biospecimens and advanced imaging data are collected for exploratory analyses, including development of machine learning tools for radiation planning. Overall survival and progression-free survival are the primary outcomes measured up to eight years after randomization.