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An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Care in the United States

StatusCompleted
PhaseNot specified
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Final enrollment: 238038 participants (planned 150000) · Study completion date changed from estimate of Jun 30, 2026 to Jun 26, 2026 · Eligibility criteria expanded, about 15 words Show 3 more changesShow less
    • Final enrollment: 238038 participants (planned 150000)
    • Study completion date changed from estimate of Jun 30, 2026 to Jun 26, 2026
    • Eligibility criteria expanded, about 15 words
  2. Minor Re-verified, no change to tracked fieldsv15
  3. Minor Primary completion date changed from estimate of Dec 31, 2025 to Mar 31, 2025 Completion date: Dec 31, 2025 to Jun 30, 2026v14 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Jun 30, 2026
  4. Minor 2 versions Re-verified since Aug 29, 2025, no change to tracked fieldsv12-v13
  5. Notable Primary and study completion dates: Jun 30, 2025 to Dec 31, 2025v11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor 4 versions Re-verified since Mar 11, 2025, no change to tracked fieldsv7-v10
  2. Minor Start date: Sep 10, 2024 to Oct 9, 2024v6
  3. Minor 2 versions Re-verified since Dec 20, 2024, no change to tracked fieldsv4-v5
  4. Minor Study Identification, Study Statusv3
  5. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting Start date changed from estimate of Oct 1, 2024 to Sep 10, 2024 · Eligibility criteria expanded, about 154 wordsv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 1, 2024 to Sep 10, 2024
    • Eligibility criteria expanded, about 154 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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This is an observational study in which data from people with chronic kidney disease (CKD) and Type 2 diabetes mellitus (T2D) are collected and studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. CKD is a long-term condition in which the kidneys' ability to work properly gradually decreases over time. It is common in people with Type 2 diabetes mellitus (T2D), a condition in which glucose levels rise in the blood. People who have T2D and CKD may also develop heart disease over time. The study drug, finerenone, is already approved for doctors to prescribe to people with CKD and T2D in the US. It blocks the activity of a protein involved in worsening kidney function. The participants in this study are allowed to take finerenone as part of their regular care from their doctors. The main purpose of the study is to learn about how safe finerenone is and how well it works in people with CKD and T2D in routine medical care. To do this, researchers will collect information about the time to first occurrence of any of the following heart-related problems for participants in the US who are taking finerenone and those who are not taking it: * Heart attacks * Hospitalization due to heart failure The data will come from the electronic healthcare records of people with CKD and T2D in the US who are allowed to take finerenone after July 2021. Researchers will track participants' data and will follow them until the occurrence of heart-related problems, the participant's data is no longer available, there is a change in the participant's treatment strategy, or the end of the study. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Trial Details
NCT Number NCT06608212
Lead Sponsor Bayer
Conditions Chronic Kidney Disease, Type 2 Diabetes Mellitus
Enrollment 238,038 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov