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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating sodium zirconium cyclosilicate SZC to treat hyperkalaemia in children under 18 years old. This Phase 3, international, open-label study aims to assess the effectiveness, safety, and tolerability of SZC. The study enrolls about 140 children from multiple countries, starting with age groups 6 to under 12 years and 12 to under 18 years. Later, younger age groups may be included based on data reviews. The goal is to see how well SZC controls potassium levels in children with this condition. The study includes three treatment phases Correction Phase CP, Maintenance Phase MP, and Long-Term Maintenance Phase LTMP. In the CP, participants receive fixed doses of SZC orally three times daily for up to 3 days until potassium levels normalize. Doses are adjusted based on body weight and age groups, with possible dose increases after safety reviews. Those who achieve normal potassium enter the 28-day MP with once daily SZC, where doses can be adjusted to maintain potassium levels. Participants may continue in the LTMP using the same dosing approach with monthly visits. Participants undergo regular monitoring including blood tests, urine tests, and ECGs to assess potassium levels, electrolytes, and heart rhythm. Researchers track safety, tolerability, potassium control, and other biochemical changes throughout the phases. The study lasts about 28 weeks, including treatment and a safety follow-up visit one week after the last dose. Data collected will help evaluate SZCs role in managing hyperkalaemia in children.
Actively Recruiting
Researchers are evaluating the effectiveness and safety of puxitatug samrotecan compared to a physicians choice of chemotherapy doxorubicin or paclitaxel in adults with advanced or metastatic endometrial cancer that has progressed after platinum-based chemotherapy and anti-PD-1anti-PD-L1 therapy. This Phase III, randomized, open-label study focuses on participants selected for B7-H4 expression and who have received no more than two prior treatments for advanced disease. Participants will be randomly assigned to receive either puxitatug samrotecan intravenously every three weeks or chemotherapy chosen by their physician. Chemotherapy options include doxorubicin given intravenously every three weeks or paclitaxel administered intravenously on days 1, 8, and 15 in a 28-day cycle. The study plans to enroll about 700 participants worldwide and compare how long participants live without cancer progression and overall survival between the two groups. During the study, participants will have regular assessments of their cancer status and quality of life. These will include imaging scans to measure tumor response and tracking of symptoms and side effects. Researchers will monitor progression-free survival, overall survival, response rates, duration of response, and time until further treatments are needed. The study will last approximately three years for outcome assessment, with safety and quality of life monitored throughout.