Bayer AG ((BAYRY)) announced an update on their ongoing clinical study.
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Study Overview: Bayer AG is conducting a clinical study titled An 18-month, Open-label, Single-arm Safety Extension Study of an age-and Bodyweight-adjusted Oral Finerenone Regimen, in Addition to an ACEI or ARB, for the Treatment of Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria. The study aims to evaluate the long-term safety and efficacy of finerenone, in combination with ACE inhibitors or angiotensin receptor blockers, in treating children and young adults with chronic kidney disease (CKD) and proteinuria. This research is significant as it seeks to improve treatment outcomes for a vulnerable population.
Intervention/Treatment: The intervention being tested is finerenone, marketed as Kerendia (BAY94-8862), a drug designed to control the overactivation of the renin-angiotensin-aldosterone system (RAAS) when used alongside ACE inhibitors or angiotensin receptor blockers. The goal is to enhance kidney function and manage proteinuria in patients with CKD.
Study Design: This Phase 3 study is interventional, with a single-group assignment and no masking. Participants will receive finerenone in an open-label format, focusing on treatment as the primary purpose. The study will monitor treatment emergent adverse events, blood pressure, and potassium levels to assess safety, while also evaluating urinary protein levels and kidney function for efficacy.
Study Timeline: The study began on July 11, 2022, and is currently recruiting participants. The primary completion and estimated study completion dates are not specified, but the last update was submitted on October 21, 2025. These dates are crucial for tracking the study’s progress and potential market impact.
Market Implications: The ongoing study by Bayer AG could influence the company’s stock performance positively if the results demonstrate significant safety and efficacy improvements. Successful outcomes could enhance investor sentiment and position Bayer favorably against competitors in the CKD treatment market, potentially expanding its market share in pediatric nephrology.
The study is ongoing, with further details available on the ClinicalTrials portal.