Research Award Recipients

Finerenone to improve acute kidney injury recovery: a multicentre randomized controlled pilot trial

Co-applicant(s): Edward Clark, Jean-François Cailhier, Josée Bouchard, Ron Wald, Samuel Silver, William Beaubien-Souligny

Lay Abstract

Background: Acute kidney injury (AKI) happens when the kidneys suddenly stop working properly, often during a hospital stay. This can be caused by infections, certain medications, or surgery. Many people who experience an AKI do not fully recover their kidney function and are at risk of developing chronic kidney disease (CKD), a long-term condition where the kidneys gradually lose their ability to clean the blood. Currently, there are no approved treatments to prevent kidney damage from progressing after an AKI episode. Recently, a new medication called finerenone was approved in Canada for people with CKD. Finerenone helps protect the kidneys by reducing inflammation and scarring, lowering protein in the urine, and slowing kidney decline. We believe that giving finerenone early after an AKI episode could help prevent the kidneys from developing long-term damage. However, finerenone has never been studied in patients with AKI, and it is not yet known whether it is safe or well-tolerated in this population.

Purpose: The Finerenone to Improve Acute Kidney Injury (FiPAKI) study is an innovative research program designed to test whether finerenone can safely be used in people with AKI. This first phase of the project is a pilot randomized controlled trial, which means it is a smaller, early-stage study done before launching a larger one. The goal is to find out if finerenone is safe, tolerable, and feasible to study in patients who have experienced AKI. This will help us plan a larger confirmatory study in the future.

Method: The FiPAKI pilot trial will include 72 hospitalized adults who have recently suffered from AKI. Participants will be randomly assigned to one of two groups: one group will receive finerenone (an oral tablet) and the other will receive a placebo (a look-alike pill with no active medication). The medication will be taken once daily for 45 days, with a 90-day follow-up to check kidney function, safety, and other health outcomes. The main goal of this pilot study is to see if the research plan is feasible—that is, if enough patients can be recruited, if they can take the study drug as prescribed, and if we can successfully follow them over time. In addition to these feasibility goals, we will also look at early signs of kidney scarring, such as blood and urine test markers that reflect kidney function and ongoing damage.

Anticipated Outcomes: We expect that finerenone will be safe and well-tolerated in people with AKI. Compared to those who receive the placebo, patients who receive finerenone may show fewer signs of sustained kidney damage and better early recovery. The information from this pilot trial will tell us whether it is appropriate and practical to move forward with a larger, definitive study to confirm these findings.

Patient Engagement: This study includes a live experience partner, someone who has personally lived through the challenges of kidney disease. He has been part of the FiPAKI research program since 2024, contributing to the design of the study to ensure the study is acceptable and realistic for patients.

Relevance to Patients and the Community: If finerenone is found to be safe and effective in this setting, it could become the first treatment to prevent CKD after AKI—a major unmet need. Because the drug is already approved and available in Canada, moving from research to real-world use could happen relatively quickly. The FiPAKI pilot study will therefore provide the essential foundation for a larger, patient-centred clinical trial that could change the way we care for patients after AKI.

Conclusions: AKI is a serious condition that can lead to permanent kidney damage and long-term complications. There are currently no therapies proven to prevent this progression. The FiPAKI study represents an important first step toward developing a treatment that could protect kidney health and improve the quality of life for thousands of people who experience AKI each year.