Triple Therapy for Type 2 Diabetes and Kidney Disease
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
Recruiting
Phase 4Interventional Study
Patients With Type 2 Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
82 (estimated)
Sponsor
Chinese University of Hong Kong · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes and chronic kidney disease to evaluate a combination treatment. Participants will take specific medications to see how they affect kidney health.
Are You a Good Fit for This Trial?
Must be takingSGLT2 inhibitorACE inhibitorARB
Rules you outType 1 diabetesAdrenal insufficiency
You may be able to join if
I am at least 18 years old.
I have been diagnosed with type 2 diabetes for at least 6 months.
I have chronic kidney disease.
I have stable kidney function.
I have normal potassium levels.
I have been taking an SGLT2 inhibitor for at least 4 weeks.
I am taking an ACE inhibitor or ARB without side effects.
I do not have any physical limitations or serious medical conditions.
You may not be able to join if
I have type 1 diabetes.
I am allergic or intolerant to ACE inhibitors or ARBs.
I cannot take mineralocorticoid receptor antagonists.
I am currently pregnant or planning to become pregnant.
My HbA1c is above 9%.
My blood pressure is too high or too low.
I have had a stroke or worsening heart failure in the past 6 months.
I am on dialysis or need a kidney transplant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
To evaluate triple therapy with nsMRA, RASi and SGLT2i on albuminuria in individuals with T2D and CKD
Trial Locations
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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 seru…
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).
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