Data Readout

Akebia's AKB-9090 begins dosing in Phase 1 trial testing kidney-injury biomarkers

The randomized, placebo-controlled study in healthy volunteers will read out safety and pharmacodynamic biomarker data by the end of 2026, the first human evidence for a candidate Akebia is developing to prevent kidney injury after cardiac surgery.

By AppliedXLJuly 13, 2026Trial NCT07429006

Executive Summary

Akebia has moved a new kidney-injury candidate into its first human study, with a safety and biomarker readout due within the year that will shape whether the drug advances toward the surgical population it is meant to protect.
The design is built around tolerability and dose-ranging pharmacodynamics, not a clinical efficacy claim, so the readout will inform dose selection rather than settle whether the drug works in patients.
Recruitment started on schedule and the enrollment target has held steady, signaling normal early-stage execution rather than any operational strain.
The candidate sits in a kidney-injury-prevention space with no approved preventive drug and no identified competitor sharing its mechanism, leaving this readout as an early, largely uncontested data point rather than one measured against rival trial results.

The trial

AKB-9090 entered its first human study under NCT07429006, a single- and multiple-ascending-dose trial in up to 70 healthy adult volunteers, randomized against placebo. Akebia said it initiated the Phase 1 study and expects topline data in early 2027, while an earlier disclosure guided investors to a 2026 readout window; the trial's own registry record lists a primary completion date of October 1, 2026. The study is running at a single site in New Zealand and moved from Not yet recruiting to Recruiting on April 13, 2026, alongside its March 16, 2026 start. NCT07429006+1

Probability of Success

Endpoint Met49%

Completes95%

Clinical Significance0%

Regulatory52%

What it will measure

The trial carries nine primary endpoints, all safety parameters: clinically significant changes in 12-lead ECG, chemistry, coagulation, hematology, lipids, physical exams, urinalysis, and vital signs, plus the incidence of serious and treatment-emergent adverse events. Its 18 secondary endpoints cover pharmacokinetics (Cmax, AUC, half-life, clearance) and pharmacodynamic biomarkers, specifically changes in erythropoietin, red blood cell count, and reticulocyte count across both the single-ascending-dose and multiple-ascending-dose cohorts. That biomarker panel is the closest proxy in this study to the biological effect Akebia will need to see before moving into patients: a drug intended to protect the kidney during cardiac surgery would be expected to show a dose-dependent erythropoietin and reticulocyte response in the ascending-dose cohorts. NCT07429006

Where it fits

Akebia's own pipeline disclosures tie AKB-9090 to prevention of cardiac surgery-associated acute kidney injury, and the company has already guided to a second, indication-specific data readout in the first half of 2027. There is no approved drug for preventing this form of kidney injury, and no competitor sharing AKB-9090's mechanism appears in the current competitive field for the drug or its indication. Akebia's broader pipeline includes commercial-stage Vafseo (vadadustat) for dialysis-related anemia, a different program in the same renal franchise, and a Phase 2 praliciguat trial in focal segmental glomerulosclerosis enrolling in parallel. Akebia+1

Execution track record

Akebia has completed 29 of 30 prior trials with one terminated, a completion rate the company's overall trial history supports, though a single-trial termination is too small a sample to characterize as a rate. The AKB-9090 study itself has recorded no protocol amendments, no change in enrollment target, and no eligibility-criteria changes since it first posted on February 24, 2026, consistent with a trial proceeding as designed. Akebia+1

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.