Observational study on the use of finerenone for chronic kidney disease and type 2 diabetes
Finerenone Research of Outcomes and Drug Utilization
This study looks at how well finerenone works and how safe it is for people with chronic kidney disease and type 2 diabetes who are already taking it as part of their regular treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 4 sites (Multiple Locations, New Jersey and 3 other locations) |
| Trial ID | NCT06278207 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data from participants in Japan and the United States who have chronic kidney disease (CKD) and type 2 diabetes (T2D) and are already receiving finerenone as part of their standard medical care. The study will monitor the safety and effectiveness of finerenone in real-world conditions without imposing any specific interventions. CKD often develops as a complication of T2D, and finerenone may help mitigate kidney damage by blocking mineralocorticoid receptors. Participants will be tracked over time to assess outcomes related to their kidney health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of chronic kidney disease stages 2-4 and a history of type 2 diabetes.
Not a fit: Patients with kidney failure or those who have been prescribed finerenone in the past 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of finerenone for patients with CKD and T2D.
How similar studies have performed: Other studies have shown promise in evaluating the effects of finerenone, making this observational approach relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used * No recorded prescription for finerenone in the 12 months prior to the index date * Age of 18 years or older as of the index date * Evidence of T2D at any point before (and including) the index date. * CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date: * A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified * two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days * two different eGFR test results ≥ 15 mL/min/1.73 m2 AND \< 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days Exclusion Criteria: \- Kidney failure defined as follows: * Two different eGFR test results \< 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days; * Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period); * A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant
Where this trial is running
Multiple Locations, New Jersey and 3 other locations
- Many Locations — Multiple Locations, New Jersey, United States (Completed)
- Bayer — Berlin, Germany (Recruiting)
- Many Locations — Multiple Locations, Japan (Completed)
- Many Locations — Multiple Locations, Taiwan (Completed)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.