Actively Recruiting
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
Led by Chinese University of Hong Kong · Updated on 2025-03-05
82
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
3M, Diabetes and Endocrine Research Center
Hong Kong, Hong Kong
Actively Recruiting
Research Team
E
Elaine Chow
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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