MinorPrimary 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
MinorPrimary completion moved earlier from Sep 1, 2027 to Nov 5, 2026
Study completion moved earlier from Dec 15, 2027 to Dec 22, 2026
v57
NotablePrimary completion pushed from Oct 26, 2026 to Sep 1, 2027
Study completion pushed from Dec 15, 2026 to Dec 15, 2027
v56
MinorPrimary completion date: Sep 30, 2026 to Oct 26, 2026v55
MinorEnrollment target: estimated 4500 to confirmed 4613v54
Show 45 earlier versionsHide 45 earlier versions
MinorRe-verified, no change to tracked fieldsv53
MinorTrial status: Recruiting to Active, Not Recruiting
Study sites: 68 to 56
v52
Minor5 versionsRe-verified since Oct 21, 2025, no change to tracked fieldsv47-v51
MinorPrimary completion date: Oct 31, 2026 to Sep 30, 2026v46
Minor4 versionsRe-verified since Jun 18, 2025, no change to tracked fieldsv42-v45
MinorPrimary completion date: Sep 30, 2027 to Oct 31, 2026
Study completion date: Jan 14, 2028 to Dec 15, 2026
v41
Minor3 versionsRe-verified since Mar 24, 2025, no change to tracked fieldsv38-v40
MinorStudy completion date: Sep 30, 2027 to Jan 14, 2028v37
Minor4 versionsRe-verified since Dec 2, 2024, no change to tracked fieldsv33-v36
MinorStudy completion date: Jan 30, 2028 to Sep 30, 2027v32
MinorEnrollment target: 5500 to 4500
Study sites: 69 to 68
Eligibility criteria revised
v31
MinorStudy sites: 72 to 69
Study completion date: Jan 1, 2028 to Jan 30, 2028
v30
MinorSite details revised at 1 of 72 sitesv29
MinorRe-verified, no change to tracked fieldsv28
MinorSite details revised at 1 of 72 sitesv27
MinorStudy sites: 71 to 72v26
MinorSite details revised at 3 of 71 sitesv25
Minor4 versionsRe-verified since Nov 15, 2023, no change to tracked fieldsv21-v24
MinorPrimary completion date: Sep 1, 2027 to Sep 30, 2027v20
MinorStudy sites: 70 to 71v19
MinorSite details revised at 1 of 70 sitesv18
MinorStudy sites: 69 to 70v17
MinorStudy sites: 68 to 69v16
NotablePrimary 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
MinorSite details revised at 4 of 68 sitesv14
MinorSite details revised at 4 of 68 sitesv13
MinorStudy sites revised (68)
Eligibility criteria expanded, about 3 words
v12
MinorStudy sites: 66 to 68v11
NotablePrimary completion date: Nov 15, 2025 to Nov 1, 2027v10Show 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
MinorStudy 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.
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.