Burgos

Researchers are evaluating the use of sodium zirconium cyclosilicate (SZC) to optimize treatment with renin-angiotensin aldosterone system inhibitors (RAASi) in elderly patients with heart failure and chronic kidney disease who have elevated or at-risk serum potassium levels. This Phase 3 randomized clinical trial aims to find the best strategy to safely increase RAASi doses to recommended levels without causing significant hyperkalemia, which often limits these treatments despite their benefits for reducing mortality and morbidity. Eligible patients have had recent heart failure decompensation requiring hospital admission and intravenous diuretics, with mild hyperkalemia or risk of developing it. Participants will be randomly assigned to receive either SZC along with RAASi therapy or standard care without potassium binders for three months. The study involves up-titrating ACE inhibitors, angiotensin receptor blockers, angiotensin receptor-neprilysin inhibitors, or mineralocorticoid receptor antagonists according to clinical guidelines. The goal is to evaluate whether SZC helps patients reach target RAASi doses safely. Treatments are managed according to European Society of Cardiology recommendations, and the study is conducted across multiple centers with an open-label, parallel group design. Throughout the study, patients will be monitored from screening to three months after inclusion to assess how many can increase their RAASi doses by at least 25%. Researchers will evaluate potassium levels, kidney function, heart failure status, and adherence to treatment. Safety and tolerability will be observed, and data on hospitalizations, adverse events, and other clinical outcomes will be collected to understand the impact of SZC on optimizing heart failure and kidney disease management in elderly patients.

Primary immune thrombocytopenia (ITP) is a condition in which the immune system mistakenly destroys platelets, the cells that help stop bleeding. This leads to a low platelet count, making it easier to bruise or bleed. The trial investigates the long-term safety, tolerability, and effectiveness of mezagitamab in adults with chronic primary ITP who have previously participated in certain mezagitamab studies. It also examines how the body processes mezagitamab over time. Participants who completed the previous mezagitamab studies TAK-079-3002 or TAK-079-1004 and meet specific criteria will receive mezagitamab as a subcutaneous injection during this continuation study. The study is open-label and multicenter, focusing on continued treatment based on protocol requirements. The medication is given under medical supervision, and participants return to the study clinic several times throughout the study. During their participation, individuals will undergo regular assessments including monitoring for treatment-emergent adverse events and serious adverse events up to approximately 108 weeks. Researchers will track safety by noting any adverse events that lead to permanent withdrawal from mezagitamab. The study includes physical evaluations, laboratory tests, and ongoing safety monitoring to understand how well participants tolerate the treatment and how effective it is over the long term.

Researchers are investigating budoprutug, a humanized immunoglobulin G1 monoclonal antibody targeting CD19, in adults with Immune Thrombocytopenia (ITP). This Phase 1b/2a, open-label, sequential-cohort study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of budoprutug. Participants have ITP with low platelet counts despite prior treatment attempts. Participants will receive budoprutug as two intravenous infusions given 14 days apart in escalating doses. The study includes dose escalation and expansion cohorts where the medication is given as a single IV dose on Day 1 and Day 15. The treatment is designed to deplete targeted cells through antibody-dependent cellular cytotoxicity. Throughout the study, researchers will monitor safety by tracking treatment-emergent adverse events up to week 48. Participants will undergo laboratory tests to confirm eligibility and monitor blood counts and other parameters. The study evaluates pharmacokinetics, pharmacodynamics, and clinical response while following participants for safety and tolerability over several weeks.

Researchers are studying patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in the United States and Europe to understand their characteristics, treatment patterns, and outcomes over time. The study focuses on individuals who are receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or failure of prior therapies. The research includes a United States sub-study to evaluate mavacamten's safety and a European sub-study to assess both its effectiveness and safety in real-world settings. Participants may receive mavacamten according to its product label or other symptomatic therapies such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide based on standard care. The study includes those starting mavacamten, currently on other treatments, or untreated due to intolerance or failure of prior therapy. Treatment is observed during routine clinical care without altering prescribed therapy. Data collection occurs over several years to monitor long-term outcomes. During the study, participants will be regularly assessed for heart function and symptoms, including measuring the left ventricular outflow tract gradient and monitoring the incidence of new or worsening heart failure up to five years. Researchers will gather information on patient health, treatment safety, and heart function changes through echocardiography and symptom evaluations. The study allows for long-term observation to better understand real-world treatment effects and outcomes in obstructive HCM patients.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the efficacy and safety of Kedrion Intravenous Human Normal Immunoglobulin 10% (IVIg 10%) in adult patients with chronic primary Immune Thrombocytopenia (ITP), a condition characterized by low platelet counts lasting over 12 months. This Phase III, open-label, single-arm, multicenter study focuses on adults aged 18 to 70 years with chronic ITP and low platelet levels, aiming to assess the treatment's response rate by day 14. The study involves administering Kedrion IVIG 10% intravenously to eligible patients. Participants will receive the treatment following screening and baseline assessments, with careful monitoring of platelet counts and health status. The protocol includes specific criteria for inclusion and exclusion to ensure patient safety and appropriate evaluation of the therapy. During the study, participants will undergo regular assessments including platelet counts, safety evaluations, and monitoring for any adverse effects. Researchers will measure the rate of patients who respond to treatment by day 14. The study also requires adherence to protocol guidelines, pregnancy testing for women of childbearing potential, and use of birth control during the trial. The total participation period covers screening, treatment, and follow-up visits as outlined in the study protocol.

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) in adults with advanced or metastatic esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed. The study focuses on patients whose disease has worsened after receiving platinum-based chemotherapy and an immune checkpoint inhibitor. This phase 3 trial compares I-DXd to chemotherapy chosen by the doctor to see which treatment helps patients live longer. Participants receive either I-DXd or one of several chemotherapy drugs, including docetaxel, paclitaxel, or irinotecan hydrochloride, all given through intravenous infusion. The goal is to assess overall survival, progression-free survival, and objective response rate. The study includes a randomized, open-label design across multiple centers. During the trial, participants are monitored regularly with scans, imaging, and clinical assessments to measure tumor response and disease progression. Researchers will track overall survival from the time of randomization up to about 54 months. Safety is closely observed throughout the study. Participants must provide tumor samples before starting treatment and have measurable lesions suitable for evaluation. The study requires an Eastern Cooperative Oncology Group performance status of 0 or 1 at baseline and includes detailed eligibility and exclusion conditions to ensure safety and appropriate selection.

Researchers are evaluating the effectiveness and safety of opevesostat combined with hormone replacement therapy compared to alternative treatments with abiraterone acetate or enzalutamide in people with metastatic castration-resistant prostate cancer (mCRPC) who have already been treated with one next-generation hormonal agent. This Phase 3 study aims to determine whether opevesostat improves radiographic progression-free survival, assessed by independent central review, in participants with or without androgen receptor ligand binding domain mutations. Participants will receive either oral opevesostat along with hormone replacement therapy drugs such as dexamethasone and fludrocortisone acetate, or they will receive alternative oral treatments including abiraterone acetate with prednisone acetate or enzalutamide. Hydrocortisone can be used as a rescue drug if needed. The study is open-label and randomized, comparing these treatment strategies in participants who have progressed after prior hormonal therapy. During the study, participants will undergo assessments including imaging scans to monitor disease progression. Researchers will measure radiographic progression-free survival up to approximately 52 months. Safety and overall survival are also monitored as secondary outcomes. Participants must attend scheduled visits for evaluations, provide tumor tissue samples, and have ongoing monitoring of organ function, hormone levels, and other relevant health parameters throughout the study period.

Researchers are investigating the safety and effectiveness of pirtobrutinib in adults with Primary Immune Thrombocytopenia (ITP), a condition where the immune system attacks platelets. This study includes a phase 1 dose-escalation to assess tolerability and side effects, followed by a phase 2 dose-optimization to compare different doses of pirtobrutinib against a placebo. The goal is to understand how well pirtobrutinib works and how safe it is for this condition. Participants will receive study drug orally, either pirtobrutinib or a placebo. The phase 1 portion lasts up to 16 weeks focusing on dose escalation, while the phase 2 portion lasts up to 28 weeks for dose optimization. Blood tests will be done to measure drug levels in the bloodstream and monitor elimination. The study excludes the initial screening period. Throughout the study, participants will have various assessments including monitoring of vital signs, laboratory tests, electrocardiograms, and evaluation of any adverse effects. The primary outcomes are safety-related events during the first 4 to 16 weeks and efficacy compared to placebo up to 24 weeks. The total study duration for participants varies based on their assigned phase and treatment group, with careful monitoring of safety and treatment responses.