Bellavista

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 AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating how well elritercept (TAK-226, KER-050) works in reducing the need for red blood cell (RBC) transfusions in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require regular blood transfusions. The study is a Phase 3, double-blind, randomized, placebo-controlled trial that also aims to assess the safety and tolerability of elritercept over both short and longer periods, including in adults with high transfusion needs. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept or a matching placebo by subcutaneous injection every 4 weeks. The study includes a Primary Phase lasting 24 weeks and a Secondary Phase lasting an additional 24 weeks, during which participants continue the same treatment. Following these phases, an Extension Phase allows eligible participants to continue treatment until discontinuation or study unblinding. Study visits occur every 2 weeks during the first 6 cycles and every 4 weeks thereafter. Treatment continuation depends on meeting disease assessment criteria every 24 weeks. Participants will undergo various assessments including bone marrow aspirates, transfusion evaluations, and disease status checks throughout the study. Safety follow-up lasts for 8 weeks after the last dose, with visits every 4 weeks during this time. Afterward, long-term follow-up occurs quarterly for up to 5 years or until withdrawal, death, loss to follow-up, or study closure. The main outcome measured is the percentage of participants achieving transfusion independence for at least 8 weeks during the first 24 weeks of treatment.

Researchers are evaluating a lab-made antibody called ePGT121v1-LS that targets a specific part of the HIV virus. This study involves generally healthy adults without HIV-1 and aims to assess the safety, side effects, dosing, how the body processes these antibodies, and how well the antibodies can neutralize HIV in the blood. The study also examines the use of ePGT121v1-LS alone and in combination with two other antibodies, VRC07-523LS and PGDM1400LS, given by different methods. Participants will be divided into two parts. In Part A, six groups will receive ePGT121v1-LS by intravenous infusion at varying doses or in combination with the other two antibodies, given at two visits spaced 24 weeks apart, with a total participation period of 48 weeks. In Part B, two groups will receive subcutaneous injections of ePGT121v1-LS alone or combined with PGDM1400LS and VRC07-523LS, with two visits 12 weeks apart, lasting 24 weeks in total. During the study, participants will attend scheduled clinic visits for safety monitoring, lab tests, and measurement of drug levels in the blood. Researchers will track adverse events, including local and systemic side effects, serious adverse events, and any early study discontinuations. They will also analyze how the body absorbs and clears the antibodies and measure antibody concentrations over time to better understand their behavior and safety in humans.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

This research aims to understand how HIV care is decentralized in Peru, an approach intended to improve ongoing care for people with HIV. Decentralizing HIV services has rarely been studied using experimental methods, especially in urban settings, so this study will provide valuable insights for decentralization efforts in Peru and other countries. It focuses on developing guidelines, identifying barriers and facilitators, and testing a care model to enhance treatment access and retention. The study combines Project ECHO with NIATx to train staff at primary health clinics (PHCs) through a hub and spoke model connecting secondary health centers (SHCs) and PHCs. Decentralization will be guided by newly created criteria and quality health indicators to improve retention in care and viral suppression. Over 24 months, the study will observe how decentralized services are adopted and scaled up in PHCs, measuring increases in treatment, retention, and viral suppression among people with HIV. Participants involved in the study include clinicians and leaders at PHCs and SHCs who will engage in surveys and training. Researchers will evaluate adoption of decentralized care, fidelity to training programs, and adherence to guidelines. The main outcome measured is the percentage of people with HIV treated in PHCs within the district over up to 54 months, helping assess the success of the decentralization approach and implementation strategies.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Central nervous system (CNS) tumors are the most common solid cancers in children and a leading cause of cancer-related deaths. While some CNS tumors like medulloblastomas are well studied, many rare embryonal tumors require more research. This international registry focuses on collecting data about rare embryonal tumors such as embryonal tumors with multilayered rosettes (ETMR), FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, and CNS tumors with BCOR internal tandem duplication. The goal is to understand clinical features, diagnosis, treatment approaches, and outcomes to improve knowledge and future care recommendations. The registry includes pediatric and young adult patients diagnosed with these rare CNS embryonal tumors since January 1, 2010. It collects detailed information through questionnaires on patient characteristics, tumor features, diagnosis methods, treatment plans, complications, late effects, outcomes, and follow-up data. This study combines both retrospective and prospective data from multiple international centers and national groups. Researchers aim to identify prognostic factors, treatment gaps, and generate evidence-based diagnostic and treatment guidelines. Participants contribute data over time, enabling researchers to monitor survival and treatment effects. The primary outcomes measured include overall survival rates at 3 and 5 years. Quality control and data management are performed by the Immune Oncology Research Institute. This registry helps gather important information on very rare CNS tumors, supporting better understanding, care, and future studies worldwide.

Researchers are evaluating the effectiveness of saruparib (AZD5305) combined with camizestrant compared to physician's choice of CDK4/6 inhibitor plus endocrine therapy or plus camizestrant in patients with advanced breast cancer. Participants must have hormone receptor-positive, HER2-negative breast cancer with specific genetic mutations in BRCA1, BRCA2, or PALB2. This is a phase III randomized, open-label study focused on first-line treatment for this patient group. Participants will be randomly assigned in a 2:2:1 ratio to one of three treatment groups: saruparib plus camizestrant; physician's choice of CDK4/6 inhibitor plus physician's choice of endocrine therapy; or physician's choice of CDK4/6 inhibitor plus camizestrant. Treatment continues until disease progression confirmed by blinded independent central review, unacceptable side effects occur, or the participant decides to stop. During the study, about 500 participants will be monitored for progression-free survival for up to approximately 59 months. Researchers will collect tissue samples and assess organ function, performance status, and treatment safety. Participants will be evaluated regularly for disease progression, treatment tolerability, and overall health throughout the study duration.

Researchers are investigating the effectiveness of Saruparib (AZD5305) combined with a physician's choice of new hormonal agents (NHA) compared to a placebo plus NHA in men with metastatic castration-sensitive prostate cancer (mCSPC). This phase III study aims to demonstrate whether Saruparib plus NHA can improve radiographic progression-free survival (rPFS) in two groups of participants: those with homologous recombination repair mutations (HRRm) and those without (non-HRRm). About 1800 adult male participants with mCSPC will be divided into two cohorts based on their HRRm status. Each cohort will be randomized equally to receive either Saruparib orally with their chosen NHA or a placebo orally with the chosen NHA. The new hormonal agents may include abiraterone acetate, darolutamide, or enzalutamide. Participants will continue their assigned treatment and undergo regular tumor evaluation scans until their disease progresses or treatment is stopped for other reasons. Throughout the study, participants will have tumor tissue and blood samples collected to confirm HRRm status and monitor disease. They will be followed for survival until the study ends. An independent data monitoring committee will review safety and tolerability of Saruparib plus NHA. The main outcome measured is radiographic progression-free survival, tracked for up to approximately 50 months, to evaluate how well the treatments control cancer progression.