Safety Study of Oral Desidustat Over 52 Weeks for Treating Anemia in Adults with Chronic Kidney Disease

What this Trial Is About

Researchers are evaluating the long-term safety of Desidustat for treating anemia in people with chronic kidney disease CKD. This Phase 4, single-arm study includes both participants who are dependent on dialysis and those who are not, aiming to gather real-world evidence on the treatments safety over one year. Participants will take oral Desidustat tablets from the start of the study up to 52 weeks. The study group includes 1004 individuals, split evenly between those on dialysis and those who are not. The treatment is monitored closely to assess any adverse events and serious adverse events throughout the duration. During the year-long study, participants will undergo regular assessments including blood tests to monitor hemoglobin levels, lipid profiles, VEGF, and serum Hepcidin. Researchers will track side effects and serious adverse events to evaluate safety. The study ends at week 52, after which participants treatment and health status will be reviewed.

A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)