Brookhaven

This research aims to evaluate the safety, tolerability, and impact on albuminuria of the drug MZE829 in adults who have proteinuric chronic kidney disease and carry the APOL1 high-risk genotype. This Phase 2 open-label study focuses on participants with specific genetic markers associated with kidney disease to better understand treatment effects. Participants will receive MZE829 in the form of oral capsules. The study involves monitoring the participants over a 12-week period to assess the drug's safety and how well patients tolerate it. Researchers will also measure changes in albuminuria, which reflects kidney function. During the study, participants will be closely monitored for any adverse events from the first day through week 12. Safety assessments and laboratory tests will be performed to track the drug’s effects. The main goal is to determine how safe and tolerable MZE829 is, along with its impact on kidney disease markers over the treatment duration.

Researchers are evaluating whether middle meningeal artery embolization (MMAE) can be used as a safer alternative to conventional open surgery for patients with moderately symptomatic chronic subdural hematoma (CSDH). This trial aims to determine if MMAE reduces the need for rescue surgery or deaths compared to standard surgery and to assess the safety of both treatments in these patients. Participants will receive either MMAE, which involves particle embolization of the middle meningeal artery using specialized embolization devices, or conventional surgery involving surgical drainage through burr holes or craniotomy. Eligible patients undergo the assigned treatment within 72 hours after randomization. The study compares these two groups to evaluate outcomes and safety. During the study, participants share their medical history, undergo physical exams, blood tests, and head CT scans, and complete questionnaires. Researchers will monitor for adverse events and measure the need for rescue surgery or death within 180 to 210 days after randomization. The total participation duration covers the time needed to assess these primary outcomes and safety.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating whether adding the drug apalutamide to the usual hormone therapy and radiation therapy after surgery improves outcomes in men with lymph node positive prostate cancer. This phase III trial focuses on patients who have had radical prostatectomy and have detectable prostate-specific antigen (PSA) indicating possible cancer recurrence. The study aims to compare metastasis-free survival between standard treatment and treatment that includes apalutamide, as well as assessing quality of life, overall survival, and treatment-related side effects. Participants are randomly assigned to one of two groups. The first group receives standard hormone therapy for 24 months along with pelvis and prostate bed radiation therapy administered 5 days a week for 5 to 8 weeks. The second group receives the same hormone and radiation therapy plus apalutamide taken orally once daily in 90-day cycles for up to eight cycles. Imaging tests like CT, MRI, bone scans, and PET scans may be done as needed. Blood samples are also collected during the study to support additional research. Throughout the study, participants undergo regular health assessments including questionnaires on quality of life and pain, as well as monitoring for any side effects. After treatment, follow-up visits occur every 6 months for 3 years and then annually to track disease progression and overall health. The primary outcome measured is the length of time participants remain free from metastatic disease or death, assessed for up to 7.5 years.

Researchers are evaluating an experimental treatment called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study focuses on testing the safety of verapamil, a drug used to treat blood vessel spasms, and its effects on the recovery process after a stroke. The study is limited to patients who have already received mechanical thrombectomy as their standard care. This trial is conducted in Phase 1 and Phase 2 to better understand the treatment's safety and potential benefits. Participants will receive intra-arterial verapamil after their mechanical thrombectomy procedure. The verapamil will be given at one of two randomized doses: 10 mg or 20 mg. The treatment is delivered directly into the artery to target the affected area. This approach aims to reduce blood vessel spasms and improve neurological outcomes following a stroke. During the study, researchers will monitor participants for bleeding complications and any serious adverse events, including death, over a three-month period. Participants will also be expected to follow up with rehabilitation therapy as part of their recovery. The study includes careful safety monitoring and assessments to understand the effects of the treatment and ensure participant well-being throughout the trial period.