START-CKD: Strategies Using Darbepoetin alfa to Avoid Transfusions in Chronic Kidney Disease
Principal Investigator: Cynthia Denu-Ciocca, MD
Sponsors: Amgen, Inc.
Description: The purpose of this research study is to evaluate 2 different ways of dosing darbepoetin alfa to reduce the need for red blood cell transfusions in people with chronic kidney disease who have anemia (low red blood cell count) and are not on dialysis. One way of dosing darbepoetin alfa will be to increase or decrease the dose every month, if needed, to adjust the hemoglobin level (measure of red blood cells). The other way of dosing darbepoetin alfa during the research study will be to give the same dose every month.
Darbepoetin alfa is a drug that increases the production of red blood cells. It has been approved by regulatory health agencies in the US and around the world (like the Food and Drug Administration [FDA] or European Medicines Agency [EMA]) to treat anemia and has been used to decrease the risk of transfusions in people with anemia due to chronic kidney disease, including people who are on dialysis and people who are not on dialysis.
For more information, including obtaining information about eligibility for this study, please contact: