Vadadustat for Anemia

Recruiting at 17 trial locations

Overseen By Akebia Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Akebia Therapeutics

Must be taking: ESA

Must not be taking: HIF-PHI

Disqualifiers: Cirrhosis, Acute liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 27 weeks

350 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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

I understand the study's procedures and have given my written consent.

My hemoglobin level is above 8 g/dl.

My blood iron levels are within the required range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vadadustat or standard of care ESA three times a week for the treatment of anemia in in-center hemodialysis

27 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vadadustat

Trial Overview

The study compares Vadadustat given three times weekly to standard of care ESAs in treating anemia among patients undergoing regular in-center hemodialysis. It's randomized and open-label, meaning both researchers and participants know which treatment is being administered.

How Is the Trial Designed?

Group I: Vadadustat Experimental Treatment 1 Intervention

Study drug will be administered three times a week.

Group II: Erythropoiesis-Stimulating Agent (ESA) Active Control 1 Intervention

Dose adjustments will be determined by hemoglobin (Hb) change and current dose of ESA, per ESA dosing protocol

Who Is Running the Clinical Trial?

Akebia Therapeutics

Lead Sponsor

Trials

35

Recruited

12,400+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12394292/

Interim Analysis of Postmarketing Surveillance in Japan

The median treatment duration was 365.0 days overall (365.0 days for NDD-CKD and PD-CKD, and 189.0 days for HD-CKD). Treatment with vadadustat ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2025956

Safety and Efficacy of Vadadustat for Anemia in Patients ...

In the incident DD-CKD trial, 83.8% of the patients in the vadadustat group and 85.5% of the patients in the darbepoetin alfa group had at least ...

3.

ajkd.org

ajkd.org/article/S0272-6386(24)01043-6/fulltext

Vadadustat Three Times Weekly in Patients With Anemia ...

This trial demonstrated that vadadustat 3 times weekly was noninferior to MPG-EPO in efficacy (mean change in hemoglobin level from baseline) ...

4.

ir.akebia.com

ir.akebia.com/news-releases/news-release-details/vadadustat-us-patient-data-global-phase-3-clinical-program

Vadadustat U.S. Patient Data from Global Phase 3 Clinical ...

Among the U.S. patient subgroup with NDD-CKD, safety and efficacy outcomes were similar, but the risk for major adverse cardiovascular event ( ...

5.

journals.lww.com

journals.lww.com/jasn/fulltext/2025/10000/safety_and_efficacy_of_vadadustat_for_the.11.aspx

Safety and Efficacy of Vadadustat for the Treatment of CKD ...

Among US patients with non–dialysis-dependent CKD, safety outcomes were similar; the relative risk for major adverse cardiovascular event with vadadustat was ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33913638/

Safety and Efficacy of Vadadustat for Anemia in Patients ...

The incidence of serious adverse events in the vadadustat group was 49.7% in the incident DD-CKD trial and 55.0% in the prevalent DD-CKD trial, ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02892149

NCT02892149 | Efficacy and Safety Study to Evaluate ...

The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, ...