Vadadustat for ARDS

Overseen By Paul Potnuru, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Bentley J. Bobrow

Must not be taking: Erythropoiesis-stimulating agents, Probenecid, others

Disqualifiers: Uncontrolled hypertension, Active malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of vadadustat for treating hospitalized patients with Acute Respiratory Distress Syndrome (ARDS), a serious lung condition often caused by infections like pneumonia. Researchers aim to determine if vadadustat can improve breathing without requiring a ventilator and ensure its safety. Participants may receive a 1200mg dose, a 900mg dose of vadadustat, or a placebo (a substance with no active drug). This trial may suit hospitalized individuals with sudden and severe breathing problems due to an infection, provided they are not on a ventilator and do not have certain other health issues, such as uncontrolled high blood pressure or liver problems. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including erythropoiesis-stimulating agents, probenecid, rifampicin, gemfibrozil, or teriflunomide. If you are on any of these, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that vadadustat is generally well-tolerated. One study found that 27.9% of people taking vadadustat experienced serious side effects, compared to 32.7% of those taking a placebo, a fake treatment. This indicates that fewer people had serious side effects with vadadustat than with the placebo.

Vadadustat is already approved for use in adults with kidney problems, indicating some level of safety. However, ongoing studies continue to examine its safety and effectiveness for treating lung issues like ARDS (Acute Respiratory Distress Syndrome). Researchers are closely examining its mechanisms and side effects for this specific condition. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Vadadustat is unique because it targets the body's response to low oxygen levels, a new approach for treating Acute Respiratory Distress Syndrome (ARDS). Most treatments for ARDS focus on supportive care like mechanical ventilation and oxygen therapy, but Vadadustat works by stimulating the production of erythropoietin, which may improve oxygen delivery in the body. Researchers are excited about Vadadustat because its novel mechanism could offer a more direct way to enhance oxygen utilization, potentially improving outcomes for ARDS patients without relying solely on ventilators.

What evidence suggests that vadadustat might be an effective treatment for ARDS?

Research has shown that vadadustat might help treat Acute Respiratory Distress Syndrome (ARDS). In this trial, participants will receive either vadadustat at different dosages or a placebo. Early results from previous studies indicated that fewer patients taking vadadustat experienced severe symptoms compared to those who took a placebo, especially by the 14th day. Studies suggest that vadadustat could help prevent ARDS, particularly in COVID-19 patients. These findings offer hope that vadadustat can aid those with lung injuries caused by infections. ^{1 2 3 6 7}

Who Is on the Research Team?

Paul Potnuru, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with nonintubated ARDS due to lung damage from pathogens. Specific eligibility criteria are not provided, but typically include age, health status, and disease severity.

Inclusion Criteria

My condition meets the global criteria for a specific lung injury not requiring a breathing tube.

Exclusion Criteria

Placed on mechanical ventilation before randomization

Patients who are currently Do Not Resuscitate (DNR) or Do Not Intubate (DNI)

I currently have an active cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive vadadustat or placebo for the treatment of nonintubated ARDS

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vadadustat

Trial Overview The study tests vadadustat at two different doses (1200mg and 900mg) against a placebo to see if it's effective and safe in treating ARDS caused by lung infections.

How Is the Trial Designed?

Group I: Vadadustat 900mg Experimental Treatment 1 Intervention

Group II: Vadadustat 1200mg Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bentley J. Bobrow

Lead Sponsor

Akebia Therapeutics Inc.

Collaborator

Trials

2

Recruited

660+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07086755

Vadadustat for the Treatment of Nonintubated Acute ... The objective of this study is to assess the efficacy and safety of vadadustat for treating hospitalized patients with nonintubated Acute Respiratory Distress ...

2. ir.akebia.com ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-announces-initial-findings-investigator

Press Release While a smaller proportion of subjects in the vadadustat group had a score of 6, 7, or 8 on the NIAID-OS than in the placebo group at Day 14, ...

3. med.uth.edu med.uth.edu/blog/2025/08/26/collaborative-research-brings-bench-findings-to-patients-with-acute-respiratory-distress-syndrome/

Collaborative research brings bench findings to patients with ... “We saw a very high likelihood that vadadustat would be beneficial in preventing ARDS during COVID-19. In particular, patients who came in and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04478071

Study Details | NCT04478071 | Vadadustat for the ... The purpose of this study is to evaluate the efficacy of vadadustat for the prevention and treatment of acute respiratory distress syndrome (ARDS) in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12282625/

Safety and Efficacy of Vadadustat Once Daily and Three ... Vadadustat three times weekly treatment resulted in similar changes in mean hemoglobin levels compared with vadadustat once daily, but was not noninferior to DA ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2024/215192Orig1s000OtherR.pdf

215192Orig1s000 OTHER REVIEW(S) - accessdata.fda.gov PMR 4613-2: “Conduct an observational study to characterize the long-term safety (up to 5 years follow up) of VAFSEO in adults with dialysis ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8647516/

Acute respiratory distress syndrome in COVID-19 According to their data, the remdesivir-treated patients showed a lower proportion of serious adverse events related to respiratory failure, ...