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Tests treatment safety and results for Patients With Type 2 Diabetes
Official title Use of Clinical-trials and Simulation Models to Estimate Cost-effectiveness of Non-steroidal Mineralocorticoid Antagonists, RASi and SGLT2i as Triple Therapy With Type 2 Diabetes and Chronic Kidney Disease
ClinicalTrials.gov ID: NCT06727409
What this study is testing
What is Finerenone?
Finerenone is an investigational medicine, being studied as a potential treatment for patients with type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 \ 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.
You likely can't join if
- 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
See the full eligibility 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 \ 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.