Patients With Type 2 Diabetes
Conditions
Keywords
Finereone, Triple therapy, Type 2 Diabetes, Chronic kidney disease
Brief summary
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
Interventions
DRUGFinerenone
Finerenone 10mg or 20 mg as tolerated on top of maximal tolerated RASi and stable SGLT2i therapy
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
in parallel fashion to optimise tolerated doses of Finerenone
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or above * Diagnosis of type 2 diabetes at least 6 months * CKD (eGFR by CKD-EPI 25-90 ml/min/1.73m2 with uACR 30 to \<300 mg/g) and/or those with severely elevated albuminuria (uACR 30-5000 mg/g) and eGFR \> 60 ml/min/1.73m2. * Patients should have a serum potassium \<4.8 mmol/l at screening * On SGLT2i (dapagliflozin or empaglifozin) at screening at stable doses for at least 4 weeks. * On ACEi or ARB at maximum tolerated dose per manufacturer's label that did not cause unacceptable side effects * In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
Exclusion criteria
* Type 1 diabetes * Allergy, contraindications or intolerance to ACEi/ARB * Contraindications or intolerance to mineralocorticoid receptor antagonists * Allergy, contraindications to SGLT2is * Currently pregnant or planning pregnancy * HbA1c \>9% at enrolment * Uncontrolled hypertension SBP \> 160mmHg or hypotension \<90 mmHg at enrolment * Concomitant therapy with eplenerone, spironolactone that cannot be discontinued. * History of stroke or worsening heart failure in the past 6 months prior to screening * Diabetic ketoacidosis, hyperosmolar hyperglycaemic state or myocardial infarction in the six months prior to screening * Patients on renal replacement therapy or likely require kidney transplant or dialysis during the study period * On concomitant strong CYP3A4 inhibitors that cannot be discontinued * Adrenal insufficiency * Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection. * An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in urine albumin creatinine ratio (uACR) | 26 weeks | urine ACR between baseline and end of study (26 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) | 26 weeks | eGFR calculated from plasma creatinine from baseline to end of study in ml/min/1.73m2 |
| Change in potassium | 26 weeks | Change in plasma potassium (mmol/l) from baseline to end of study |
| Change in blood pressure | 26 weeks | Change in systolic and diastolic blood pressure (mmHg) from baseline to end of study |
| Change in heath related quality of life | 26 weeks | change in HRQoL from baseline to end of study using EQ5D |
| Change in body weight | 26 weeks | Change in body weight (kg) from baseline to end of study |
Countries
Hong Kong
Contacts
Primary ContactElaine Chow
Outcome results
None listed