Evaluating a triple therapy for type 2 diabetes and chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of a triple therapy regimen combining non-steroidal mineralocorticoid antagonists, RAS inhibitors, and SGLT2 inhibitors in reducing albuminuria in patients with type 2 diabetes and chronic kidney disease. The trial will involve adult participants who have been diagnosed with type 2 diabetes for at least six months and meet specific kidney function criteria. The primary focus is on understanding the cost-effectiveness of this treatment approach through clinical trials and simulation models.

Why it matters

Who can join: the full rules

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).

Where it's running

• 3M, Diabetes and Endocrine Research Center
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Elaine Chow
• Email: e.chow@cuhk.edu.hk
• Phone: +852 35051641

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.