Rheumatoid arthritis with diabetes and chronic kidney disease
Conditions
Interventions
None listed
Sponsors
Gifu Prefectural Medical Center, Department of General Internal Medicine and Rheumatology, Hideyuki Okada
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with rheumatoid arthritis and diabetes mellitus who are aged 18 years or older, regardless of gender or whether they are in an outpatient or hospitalized setting. Patients who meet the diagnostic criteria for diabetes (fasting blood glucose 126 mg/dL or higher, 2-hour value 200 mg/dL or higher, HbA1c 6.5% or higher) or who have met the criteria in the past and have been diagnosed with diabetes, and who have stage 2 diabetic nephropathy (urinary microalbumin/creatinine ratio 30-299 mg/gCRE), stage 3 diabetic nephropathy (urinary microalbumin/creatinine ratio 300 mg/gCRE or higher), stage 4 diabetic nephropathy (estimated glomerular filtration rate (eGFR) 30 mL/min/1.73 m2 or lower), or stage 2 chronic kidney disease with diabetes (eGFR less than 89 mL/min/1.73 m2) or higher.
Exclusion criteria
Exclusion criteria: Patients with hypersensitivity to finerenone Patients who meet the contraindications listed in the package insert for finerenone (patients with a history of hypersensitivity to the ingredients of this drug, patients receiving preparations containing itraconazole/ritonavir, preparations containing atazanavir/darunavir/fosamprenavir/cobicistat, patients receiving clarithromycin/ensitrevir, patients with serum potassium levels exceeding 5.5mEq/L at the start of administration of this drug, patients with severe liver dysfunction (Child-Pugh classification C), patients with taste impairment) Patients who have experienced adverse effects after administration of finerenone and have difficulty continuing administration Patients who are currently receiving or have previously received finerenone or drugs with a similar mechanism of action, such as esaxerenone, eplerenone, or spironolactone Patients who have requested to discontinue this study by opting out
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint Improvement of fibrosis markers in each organ at 52 weeks of administration compared to before administration of finerenone (lung... KL-6, SP-D, liver...hyaluronic acid, M2BPGi, FIB4index, kidney...urinary and blood beta 2 microglobulin, urinary NAG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints Improvement and change rate of fibrosis markers in each organ, respiratory function, eGFR, UPCR and UACR, PRO index, and CT images in the finerenone group before administration, and at 4, 12, 24, and 52 weeks of administration, and comparison of these items with the non-finerenone group | — |
Countries
Japan
Contacts
Public ContactHideyuki Okada
Gifu Prefectural General Medical Center Department of General Intrenal Medicine and Rheumatology
Outcome results
None listed