Type 2 diabetes Type 2 diabetes, Diabetic nephropathy
Conditions
Interventions
Spironolactone, Finerenone
Sponsors
Takayama Shohei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria (1) Patients with type 2 diabetes (2) Patients who are 20 years of age or older at the time of consent (3) Patients with an eGFR of 30 or greater (mL/min/1.73m2) on examination within 13 weeks prior to obtaining consent (4) UACR (urinary albumin to creatinine ratio) greater than or equal to 30 and less than 5000 (mg/gCr) within 13 weeks prior to obtaining consent (5) Patients taking RAS inhibitors and SGLT-2 inhibitors for at least 180 days prior to obtaining consent (6) Patients who have not been taking MR antagonists including spironolactone and finelenone for at least 90 days prior to obtaining consent (7) Patients who have given a full explanation of their participation in this study and have given written consent of their own free will.
Exclusion criteria
Exclusion criteria: Exclude any of the following (1) Patients with a serum pottasium level of 5.0 or greater (mEq/L) on examination within 13 weeks prior to obtaining consent (2) Patients with allergy to MRAs including spironolactone and finelenone (3) Pregnant or lactating female patients (4) Other patients deemed inappropriate as subjects by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean change from baseline in UACR after 26 weeks of drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Geometric mean change from baseline in UACR after 12 weeks of drug administration (2) Change from baseline in urinary albumin/creatinine ratio after 12, 26 weeks (3) Change from baseline in systolic and diastolic blood pressure after 12, 26 weeks of treatment with study drug (4) Percentage transition of albuminuria class | — |
Contacts
Public ContactShohei Takayama
Shinshu University
Outcome results
None listed