A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

StatusActive, Not Recruiting
PhaseNot specified
SponsorBayer
Started

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Record History

The 50 most recent of 58 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion date changed from estimate of Nov 5, 2026 to Sep 28, 2026
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 20 of 56 sites
    • Publications: details revised at 2 of 2 entries
  2. Minor Primary completion moved earlier from Sep 1, 2027 to Nov 5, 2026
    • Study completion moved earlier from Dec 15, 2027 to Dec 22, 2026
    v57
  3. Notable Primary completion pushed from Oct 26, 2026 to Sep 1, 2027
    • Study completion pushed from Dec 15, 2026 to Dec 15, 2027
    v56
  4. Minor Primary completion date: Sep 30, 2026 to Oct 26, 2026v55
  5. Minor Enrollment target: estimated 4500 to confirmed 4613v54
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv53
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 68 to 56
    v52
  3. Minor 5 versions Re-verified since Oct 21, 2025, no change to tracked fieldsv47-v51
  4. Minor Primary completion date: Oct 31, 2026 to Sep 30, 2026v46
  5. Minor 4 versions Re-verified since Jun 18, 2025, no change to tracked fieldsv42-v45
  6. Minor Primary completion date: Sep 30, 2027 to Oct 31, 2026
    • Study completion date: Jan 14, 2028 to Dec 15, 2026
    v41
  7. Minor 3 versions Re-verified since Mar 24, 2025, no change to tracked fieldsv38-v40
  8. Minor Study completion date: Sep 30, 2027 to Jan 14, 2028v37
  9. Minor 4 versions Re-verified since Dec 2, 2024, no change to tracked fieldsv33-v36
  10. Minor Study completion date: Jan 30, 2028 to Sep 30, 2027v32
  11. Minor Enrollment target: 5500 to 4500
    • Study sites: 69 to 68
    • Eligibility criteria revised
    v31
  12. Minor Study sites: 72 to 69
    • Study completion date: Jan 1, 2028 to Jan 30, 2028
    v30
  13. Minor Site details revised at 1 of 72 sitesv29
  14. Minor Re-verified, no change to tracked fieldsv28
  15. Minor Site details revised at 1 of 72 sitesv27
  16. Minor Study sites: 71 to 72v26
  17. Minor Site details revised at 3 of 71 sitesv25
  18. Minor 4 versions Re-verified since Nov 15, 2023, no change to tracked fieldsv21-v24
  19. Minor Primary completion date: Sep 1, 2027 to Sep 30, 2027v20
  20. Minor Study sites: 70 to 71v19
  21. Minor Site details revised at 1 of 70 sitesv18
  22. Minor Study sites: 69 to 70v17
  23. Minor Study sites: 68 to 69v16
  24. Notable Primary endpoints revised (7)
    • Primary completion date: Nov 1, 2027 to Sep 1, 2027
    • Eligibility criteria expanded, about 13 words
    • Site details revised at 1 of 68 sites
    v15
  25. Minor Site details revised at 4 of 68 sitesv14
  26. Minor Site details revised at 4 of 68 sitesv13
  27. Minor Study sites revised (68)
    • Eligibility criteria expanded, about 3 words
    v12
  28. Minor Study sites: 66 to 68v11
  29. Notable Primary completion date: Nov 15, 2025 to Nov 1, 2027v10 Show 4 more changesShow less
    • Enrollment target: 4000 to 5500
    • Study sites: 65 to 66
    • Study completion date: Mar 15, 2026 to Jan 1, 2028
    • Secondary endpoints: details revised at 2 of 2 entries
  30. Minor Study sites: 61 to 65v9
  • 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 people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: * Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants * Reasons for starting finerenone * Reasons for stopping finerenone early * How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) * Dosing of finerenone * Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: * Stopping finerenone treatment too early * Dialysis (a medical procedure to filter the blood of extra water and waste) * Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.
Trial Details
NCT Number NCT05348733
Lead Sponsor Bayer
Conditions
(from sponsor)
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Enrollment 4,613 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov