An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score

Study acronym: FINEXPLORER
StatusRecruiting
PhaseNot specified
SponsorBayer
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Apr 30, 2029 → May 31, 2029
See other at-risk trials from Bayer

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary and study completion pushed from Apr 30, 2029 to May 31, 2029
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 26 entries
    • Site details revised
  2. Notable Recruitment opened
    • Start date changed from estimate of May 31, 2026 to May 26, 2026
    • Site details revised
    v3
  3. Notable Start date: Apr 30, 2026 to May 31, 2026
    • Site details revised
    v2
  4. Minor Study First Submitted
  • 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.
131 trials monitored
See 11 trials at risk
5,101 trials monitored
See 233 trials at risk
2,236 trials monitored
See 113 trials at risk
This is a prospective observational study in which data from people with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) who will be receiving finerenone are collected and analyzed. Chronic kidney disease (CKD) is common in people with type 2 diabetes. It can get worse over time and may lead to kidney failure and heart problems. Doctors often track kidney health using blood and urine tests, including the estimated glomerular filtration rate (eGFR) and the urine albumin-to-creatinine ratio (UACR). There are also tools that combine routine laboratory test results to estimate a person's risk of their kidney disease getting worse. One of these tools is called the Klinrisk model. The study drug, finerenone, is already approved for doctors to prescribe to patients with CKD associated with T2D and albumin in the urine. Finerenone works by blocking the mineralocorticoid receptor, a protein involved in inflammation and scarring in the kidneys and heart. The study drug, finerenone, is a non-steroidal mineralocorticoid receptor modulator that aims to reduce harmful kidney and heart changes. The main purpose of this study is to determine whether the Klinrisk score improves after 2 years of treatment with finerenone in adults with CKD associated with T2D who are treated in routine care. To achieve this, researchers will collect data on: * Clinical characteristics of participants, including their medical history related to CKD and T2D. * Variables used to assess the CKD progression, such as eGFR, UACR, and Blood Urea Nitrogen (BUN). * Participants' glucose, hemoglobin and potassium levels. The study will also monitor any medical problems (known as adverse events) that participants may experience during the study. All adverse events will be recorded, regardless of whether they are related to the treatment. Data will be collected from April 2026 to April 2029 and will cover a period of up to 24 months per participant. Data collection will occur over 5 visits that coincide with routine clinical care: inclusion, follow-up visits at 6, 12, and 18 months (±1 month), and a final visit at 24 months (±1 month).
Trial Details
NCT Number NCT07554469
Lead Sponsor Bayer
Conditions
(from sponsor)
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Related terms Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov