Vadadustat for Anemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if vadadustat, taken three times a week, matches the effectiveness of the usual treatment for anemia in individuals undergoing dialysis due to end-stage kidney disease. Anemia occurs when the body lacks enough healthy red blood cells to carry oxygen. Some parts of the study will examine changes in red blood cells with different treatments. The trial seeks participants who have been on dialysis at least three times a week and are already using or need anemia medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot use any hypoxia-inducible factor prolyl hydroxylase inhibitors (a type of medication) while participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that vadadustat, a treatment for anemia in people with chronic kidney disease, is about as safe as other available treatments. In some studies, approximately 50% of people taking vadadustat experienced serious side effects, a rate similar to other anemia drugs. Vadadustat also helps maintain stable hemoglobin levels, comparable to current treatments. Overall, vadadustat is considered well-tolerated, meaning most people do not experience severe side effects.12345
Why do researchers think this study treatment might be promising?
Vadadustat is unique because it targets anemia by stimulating the production of erythropoietin, a hormone that helps make more red blood cells. Unlike traditional erythropoiesis-stimulating agents (ESAs), which are the current standard for treating anemia, Vadadustat works by inhibiting an enzyme called prolyl hydroxylase, which can lead to more natural production of erythropoietin in the body. This mechanism mimics the body's natural response to low oxygen levels, potentially offering a more balanced approach to managing anemia. Researchers are excited because Vadadustat may provide a more consistent response in hemoglobin levels with fewer side effects, offering a promising alternative to existing treatments.
What evidence suggests that vadadustat might be an effective treatment for anemia?
Research has shown that vadadustat, which participants in this trial may receive, effectively treats anemia in patients on dialysis. One study found that taking vadadustat three times a week worked as well as another treatment, MPG-EPO, in increasing hemoglobin levels. Hemoglobin, the part of red blood cells that carries oxygen throughout the body, plays a crucial role in managing anemia. Most patients taking vadadustat achieved treatment results similar to those using other common anemia treatments. This suggests that vadadustat is a strong option for managing anemia in patients with end-stage kidney disease on hemodialysis.13567
Are You a Good Fit for This Trial?
This trial is for adults with end-stage kidney disease (ESKD) who are on in-center hemodialysis at least three times a week and have anemia. They must understand the study, consent to it, be prescribed or eligible for ESA treatment, have hemoglobin levels above 8 g/dl, and adequate iron levels.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive vadadustat or standard of care ESA three times a week for the treatment of anemia in in-center hemodialysis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Vadadustat
Find a Clinic Near You
Who Is Running the Clinical Trial?
Akebia Therapeutics
Lead Sponsor