A study using an investigational medicine for people who have anemia and kidney disease
Brief Description Of Study
This study is being carried out to see if an investigational drug called roxadustat is safe and effective in treating anemia in patients with chronic kidney disease who are not on dialysis.
Detailed Study Description
This study is being carried out to see if an investigational drug called roxadustat is safe and effective in treating anemia in patients with chronic kidney disease who are not on dialysis. This is done by comparing roxadustat with placebo (a pill that is similar in appearance but does not have any active medicine). “Investigational” means that the study drug is currently being tested. It is not approved by the U.S. Food and Drug Association (FDA). Roxadustat is an investigational drug given as a pill and it works by imitating the body’s normal response to low oxygen which occurs for example at high altitudes. Thus, roxadustat increases the production of a hormone in the body called erythropoietin which regulates the formation of red blood cells. This results in correction of anemia. This study is conducted to assess the cardiovascular safety of roxadustat, i.e. whether major adverse cardiovascular events (heart attack, stroke, heart failure, heart-related death) are affected by treatment. In addition, the potential positive effects of roxadustat on anemia, anemia associated symptoms and quality of life will be evaluated.
Additional Information About The Study
The study involves a number of visits. In the beginning of the study, you will be contacted by telephone at Week 1, and will come for visits every two weeks from Weeks 2 to approximately 5 months. From 5 months through 1 year of the start of the study, you will come for monthly visits. From 1 year through the end of the study, you will need to come for visits approximately every 2 months until the end of the study. The study will stop when decided by AstraZeneca, when enough data has been collected to evaluate the results. The treatment duration is variable for individual patients but is estimated to be between one and two years. • Screening Period: Up to 6 weeks • Treatment Period: Patients will be randomized (1:1) to double-blind treatment with roxadustat or placebo. A study end date will be declared and common closeout will occur when the target number of CV events has been accrued. The duration of treatment is estimated to vary between 1 and 2 years • Post-Treatment Follow-Up Period: 4 weeks