Clinical trial NCT06727409: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Patients With Type 2 Diabetes
Keywords: Finereone, Triple therapy, Type 2 Diabetes, Chronic kidney disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: in parallel fashion to optimise tolerated doses of Finerenone
Primary purpose: TREATMENT

Brief summary: To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD


Eligibility criteria: 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).

Primary outcomes:
measure: Change in urine albumin creatinine ratio (uACR)
timeFrame: 26 weeks
Secondary outcomes:
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: 26 weeks
measure: Change in potassium
timeFrame: 26 weeks
measure: Change in blood pressure
timeFrame: 26 weeks
measure: Change in heath related quality of life
timeFrame: 26 weeks
measure: Change in body weight
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: 3M, Diabetes and Endocrine Research Center
Study officials:
References: