Study of Darbepoetin Treatment for Adults Awaiting Liver Transplant to Reduce Blood Transfusions Randomized Phase 3 Clinical Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are conducting a national multicenter randomized clinical trial to study the effects of darbepoetin DP in patients waiting for a liver transplant. The trial aims to assess the safety and effectiveness of DP in reducing the need for red blood cell transfusions during liver transplant surgery. This phase 3 study also explores how DP influences hemoglobin levels, postoperative complications, graft survival, patient survival, and blood clotting markers in patients with chronic liver disease. Participants will be randomly assigned to one of two groups the intervention group will receive darbepoetin at a dose of 1.5 mcgkg by subcutaneous injection once a month, up to three doses or until liver transplant occurs. The control group will not receive darbepoetin. All participants will be evaluated for vitamin B12 and folic acid deficiencies, receiving supplements if needed, and will receive monthly intravenous ferric carboxymaltose as standard care. Participants will be followed for three months post-transplant to monitor outcomes. During the study, participants will undergo evaluations to monitor hemoglobin, coagulation markers, and postoperative health status, including complications and survival rates up to 12 months after transplant. Researchers will also assess quality of life and treatment-related side effects. The primary outcome is the reduction in red blood cell transfusions during surgery. Safety and effectiveness data will be collected regularly throughout the study period, which lasts up to one year on average from enrollment.

Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial)