Burgos

Researchers are evaluating the use of sodium zirconium cyclosilicate SZC to help optimize renin-angiotensin aldosterone system inhibitor RAASi therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.

Primary immune thrombocytopenia ITP is a condition where the immune system mistakenly destroys platelets, leading to a lower number of platelets and increased risk of bruising or bleeding. This Phase 3 study evaluates the long-term safety, tolerability, and effectiveness of mezagitamab in adults with chronic primary ITP. The study also investigates how the body processes mezagitamab over an extended period. Participants who completed previous mezagitamab studies TAK-079-3002 or TAK-079-1004 will be invited to join this continuation trial. Eligible participants may receive mezagitamab injections on demand, with treatment courses repeated as needed based on specific criteria and the investigators clinical judgment. The treatment is administered subcutaneously. During the study, participants will visit the clinic several times for assessments. Researchers will monitor safety by tracking treatment-emergent adverse events, and evaluate effectiveness through platelet response and remission rates. Measurements of drug levels and antibodies will also be taken. The study may last up to approximately 108 weeks, allowing detailed long-term follow-up.

Researchers are evaluating budoprutug, a humanized monoclonal antibody targeting CD19, in adults with immune thrombocytopenia ITP, a condition characterized by low platelet counts. This Phase 1b2a open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical effects of budoprutug in patients with platelet counts below 30,000L despite prior treatment attempts. The study is sponsored by Climb Bio, Inc. Participants will receive budoprutug as two intravenous infusions administered 14 days apart. The study includes sequential cohorts with escalating doses, followed by a dose expansion group. Each participant receives a single IV dose on Day 1 and another on Day 15. The trial monitors the effects of budoprutug on platelet counts and CD20 B-cell levels, among other factors. Throughout the study, participants will be closely monitored up to 48 weeks for treatment-related side effects, blood levels of the drug, immune cell changes, platelet responses, and the development of anti-drug antibodies. Safety labs including coagulation tests and bilirubin levels will be assessed. The study does not include placebo groups and participation involves scheduled visits for infusions and follow-up evaluations to track both safety and preliminary clinical outcomes over nearly a year.

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are studying real-world patient characteristics, treatment patterns, and both short- and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM across the United States and Europe. The study focuses on patients receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or prior treatment failure. The U.S. portion evaluates the safety of mavacamten in this setting, while the European part assesses both its effectiveness and safety. Participants receive treatments as part of standard care, either mavacamten or other medications such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide. Treatments are prescribed by physicians according to routine clinical management. The study observes outcomes over time without altering prescribed care. During the study, participants are monitored for changes in heart function, symptoms, and adverse events through clinical assessments including echocardiography and patient-reported questionnaires. Researchers evaluate heart failure events, heart function measures like left ventricular outflow tract gradient and ejection fraction, arrhythmias, hospitalizations, mortality, and quality of life scores. Data is collected at baseline and followed for up to five years to understand real-world treatment effects and safety.

Researchers are evaluating the efficacy and safety of Kedrion Intravenous Immunoglobulin 10% IVIg 10% in adult patients with chronic primary immune thrombocytopenia ITP, a condition characterized by low platelet counts lasting more than 12 months. This phase 3 study aims to assess how well this treatment works and its tolerability in adults aged 18 to 70 years with chronic ITP. Participants will receive one course of Kedrion IVIg 10% at a dose of 2 gkg, administered intravenously over 2 days. This single-group interventional study involves only this treatment, with no placebo or comparator. The treatment is given once, and participants will be followed up to 30 days after administration to monitor response and safety. During the study, participants will undergo platelet count assessments and evaluations for response to treatment, including complete response and time to platelet count improvement. Researchers will also monitor regression of hemorrhages and assess safety and tolerability from the first day of treatment through the end of the 30-day study period. The primary outcome measure is the rate of subjects with a response by day 14 after treatment.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are studying ifinatamab deruxtecan I-DXd in adults with advanced or metastatic esophageal squamous cell carcinoma ESCC that cannot be surgically removed and who have seen their disease worsen after treatment with platinum-based chemotherapy and immune checkpoint inhibitors. The study aims to compare I-DXd with chemotherapy chosen by the investigator to evaluate overall survival and other key outcomes. Participants will be randomly assigned to receive either I-DXd given through an intravenous infusion at 12 mgkg every 21 days or one of several chemotherapy drugs docetaxel, paclitaxel, or irinotecan hydrochloride administered intravenously. The study will continue to assess these treatments throughout multiple 21-day cycles. During the trial, participants will be monitored for overall survival, progression-free survival, tumor response, and quality of life using questionnaires. Safety will be closely tracked by recording adverse events and measuring drug levels in the blood. The study may last up to approximately 54 months for each participant, with regular assessments including imaging scans and laboratory tests to follow the disease and treatment effects.

Researchers are evaluating the efficacy and safety of opevesostat combined with daily corticosteroids compared to alternative treatments abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer mCRPC who have previously been treated with one next-generation hormonal agent NHA. The study aims to determine if opevesostat offers better control of disease progression assessed by radiographic progression-free survival, including participants with and without androgen receptor ligand binding domain mutations. Overall survival has also been included as a secondary outcome measure. Participants are randomly assigned to one of two groups. One group receives opevesostat 5 mg orally twice daily, plus dexamethasone 1.5 mg and fludrocortisone acetate 0.1 mg orally once daily, continuing until disease progression. Hydrocortisone is available as a rescue medication if needed. The other group receives either abiraterone 1000 mg once daily with prednisone 5 mg twice daily or enzalutamide 160 mg once daily, also until disease progression. This open-label, phase 3 study compares these two treatment approaches in a parallel design. During the study, participants undergo regular assessments including imaging scans to measure disease progression, safety monitoring, and evaluations of overall survival and quality of life. Researchers track radiographic progression-free survival for up to 52 months and secondary outcomes such as overall survival, time to new treatments, pain progression, and prostate-specific antigen PSA responses for up to approximately 82 months. Participants are closely monitored for adverse events and treatment tolerability throughout the study duration, which spans several years.

Researchers are studying pirtobrutinib, an oral drug, in adults with Primary Immune Thrombocytopenia ITP, a condition where the immune system reduces platelet counts. The study includes a Phase 1 dose-escalation to evaluate tolerability and side effects, followed by a Phase 2 dose-optimization to further assess efficacy and safety compared to a placebo. This research aims to find safe and effective doses for managing ITP. Participants receive pirtobrutinib orally or a placebo in a randomized, double-blind design. Phase 1 lasts about 16 weeks focusing on dose escalation, while Phase 2 lasts about 28 weeks for dose optimization. Blood tests are performed to measure drug levels and how the body clears it. During Phase 2, participants may receive different dosages of pirtobrutinib or placebo to compare effects. Throughout the study, participants undergo blood tests and clinical assessments to monitor safety, including adverse events, vital signs, lab tests, and electrocardiograms. Efficacy is measured by platelet counts and disease control over up to 24 weeks. The study also tracks how pirtobrutinib behaves in the body. Participation lasts up to 28 weeks excluding screening, with close monitoring for safety and response.