An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Finerenone Research of Outcomes and Drug Utilization
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses existing health records from adults in Asia and the United States who have long-term kidney disease and type 2 diabetes and take finerenone. Researchers will learn who uses this medicine, how safe it is, and how well it works in regular care. No extra visits or tests are needed.
This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems. The researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone. The data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older on the study’s reference date.
- Have at least 12 months of continuous records in the database, with medical and prescription drug coverage.
- Have no recorded finerenone prescription in the 12 months before the reference date.
- Have evidence of type 2 diabetes on or before the reference date.
- Have evidence of kidney disease on or before the reference date through a diagnosis or test results listed below.
- A recorded diagnosis of kidney disease at stage 2, 3, or 4, or with no stage listed.
- Two urine albumin-to-creatinine ratio (UACR) results of at least 30 mg/g, taken 90–540 days apart. This test measures protein in urine.
- Two estimated kidney filtering rate (eGFR) results of at least 15 but below 60 mL/min/1.73 m², taken 90–540 days apart.
Who can't join
- Two kidney filtering rate (eGFR) results below 15 mL/min/1.73 m², taken 90–540 days apart.
- Depend on dialysis, a treatment that cleans the blood: at least 3 sessions over at least 90 days during the period before the study’s reference date.
- Have a recorded diagnosis of kidney failure or stage 5 kidney disease.
- Have had a kidney transplant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
NJ
- Many Locations · Multiple Locations, NJ 07981More trials in Multiple Locations