Chronic Kidney Disease, Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a post-authorization safety study (PASS) to describe the real-world use of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D) in China. The study will examine baseline characteristics, comorbidities, and comedications of patients who initiate finerenone treatment. It will also evaluate changes in kidney function markers including estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and serum potassium levels over time. The study will assess hyperkalemia incidence, hospitalization rates associated with hyperkalemia, and finerenone dose titration patterns. This retrospective observational cohort study uses data from the Tianjin Healthcare and Medical Big Data Platform covering approximately 15 million residents. The study aims to provide evidence on finerenone safety and effectiveness in routine clinical practice in China, complementing data from controlled clinical trials. Results will inform healthcare providers about real-world finerenone use patterns and outcomes in Chinese patients with diabetic kidney disease.
Interventions
Retrospective cohort analysis using the EHR data from the Tianjin Healthcare and Medical Big Data Platform (China) database.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum of 12 months continuous enrolment before the index date in the database with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the electronic health record system * No recorded prescription of finerenone prior to the index date * Age 18 years or older as of the index date * Diabetic kidney disease diagnosis by diagnosis texts at any point before (and including) the index date, OR * T2D diagnosis at any point before (and including) the index date using the same algorithms as in previous studies of the FIRST program, AND * 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/text indicating CKD stage 2, 3, 4, or stage unspecified OR * Two UACR test results ≥30 mg/g separated by at least 90 days and no more than 548 days. OR • 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 no more than 548 days.
Exclusion criteria
* Type 1 diabetes mellitus identified by diagnosis codes/texts in the patient record on or before the index date * Kidney cancer identified by diagnosis codes/texts on or before the index date * Kidney failure on or before the index date, defined as: * Two different eGFR test results \<15 mL/min/1.73 m2 separated by at least 90 days and no more than 548 days OR * Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period) OR * A diagnosis code/text indicating kidney failure or CKD stage 5 OR * A recorded diagnosis indicating kidney transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive summary of characteristics of patients who initiate finerenone and have CKD and T2D in China. | Up to 365 days |
| Descriptive summary of comorbidities of patients who initiate finerenone and have CKD and T2D in China. | Up to 365 days |
| Descriptive summary of comedications of patients who initiate finerenone and have CKD and T2D in China. | Up to 180 days |
Secondary
| Measure | Time frame |
|---|---|
| To describe the routine monitoring of UACR, eGFR, and serum potassium before and after initiating finerenone in patients with CKD and T2D | Up to 32 months |
| To describe the absolute levels and relative changes over time of UACR, eGFR, and serum potassium after initiating finerenone in patients with CKD and T2D | Up to 32 months |
| To describe the incidence of hyperkalemia and the incidence of hospitalization associated with a hyperkalemia event after initiating finerenone in patients with CKD and T2D | Up to 32 months |
| To describe the number of patients who initiate finerenone using a 10 mg dose and the proportion of patients who have up-titrated to a 20 mg dose by 1, 3, 6, and 12 months, respectively, depending on data availability | Up to 32 months |
Countries
China
Outcome results
None listed