Vadadustat vs Darbepoetin Alfa: CKD Treatment Comparison
- A recent analysis published in the Journal of the American Society of Nephrology examines the safety and efficacy of vadadustat (Vafseo) compared to darbepoetin alfa (Aranesp) in treating...
- However, the analysis revealed a notable difference in major adverse cardiovascular events (MACEs).
- The FDA approved vadadustat in March 2024 for adults with CKD-related anemia who have been on dialysis for at least three months.
Decipher the latest findings: vadadustat shows similar effectiveness to darbepoetin alfa in treating anemia linked to chronic kidney disease (CKD), especially for dialysis-dependent patients. However, the analysis unveiled a notable difference in major adverse cardiovascular events (MACEs), with a higher risk observed with vadadustat outside the U.S. in non-dialysis patients.Approved by the FDA in March 2024, this onc-daily oral medication stimulates the body, boosting red blood cell production. News Directory 3 investigates the nuances of these treatments. Explore the regional variations influencing risks and outcomes. Discover what’s next for CKD anemia management.
vadadustat’s Efficacy and Safety Profile in CKD-Related anemia Treatment
Updated June 06, 2025
A recent analysis published in the Journal of the American Society of Nephrology examines the safety and efficacy of vadadustat (Vafseo) compared to darbepoetin alfa (Aranesp) in treating anemia related to chronic kidney disease (CKD).The study found that both treatments showed similar efficacy in dialysis-dependent CKD (DD-CKD) patients, both within and outside the U.S.
However, the analysis revealed a notable difference in major adverse cardiovascular events (MACEs). While U.S.patients with non-dialysis-dependent CKD (NDD-CKD) experienced similar MACE risks with both treatments, those outside the U.S.showed a higher risk with vadadustat.
The FDA approved vadadustat in March 2024 for adults with CKD-related anemia who have been on dialysis for at least three months. This once-daily oral medication stimulates the body’s natural response to low oxygen levels,boosting erythropoietin production and,consequently,increasing hemoglobin and red blood cell production. Akebia Therapeutics reported that the treatment has been available in the U.S.sence January 2025.
The global clinical program for vadadustat included four phase 3 trials comparing it to darbepoetin alfa in CKD patients with anemia. These trials considered regional variations in treatment approaches, including hemoglobin targets.
The primary safety endpoint was the first occurrence of MACE, encompassing death from any cause, nonfatal myocardial infarction, or stroke. The primary efficacy endpoint was the change in hemoglobin levels from baseline to average values during weeks 24 through 36.
In the U.S. subgroup,MACE risk was similar between the vadadustat and darbepoetin alfa groups. Though, among non-U.S. patients, the MACE risk was numerically higher in the vadadustat group, particularly within the NDD-CKD subgroup.Hemoglobin changes and adverse event rates were similar across all regions and treatment groups.
“Geographic-specific prespecified analyses of the vadadustat global phase 3 clinical program are important data as physicians in the US are making care decisions for patients with CKD-related anemia,” said dr. Steven K. Burke, chief medical officer at Akebia Therapeutics.
What’s next
Further research is needed to understand the regional differences in MACE risk associated with vadadustat in NDD-CKD patients. This will help inform treatment decisions and optimize patient outcomes in different parts of the world.