Sheikhpura

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are evaluating the long-term safety of Desidustat, an oral medication, for treating anemia in adults with chronic kidney disease (CKD). This Phase 4 study includes both dialysis-dependent and dialysis-independent patients, aiming to gather real-world safety data over a one-year period. A total of 1004 participants are planned, equally divided between those on dialysis and those not requiring dialysis. Participants will receive Desidustat tablets and be monitored for 52 weeks in this single-arm, multicenter trial. The study includes a comprehensive assessment of treatment-emergent adverse events and serious adverse events throughout the treatment period. The research aims to provide extended safety information after Desidustat's market approval. During the study, participants will undergo regular evaluations including clinical assessments, laboratory tests, and safety monitoring. Researchers will track changes in hemoglobin levels and watch for any side effects or complications. The study also involves periodic follow-up visits to ensure ongoing safety and to measure the overall impact of Desidustat treatment over the full year.