Evaluating a triple therapy for type 2 diabetes and chronic 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
PHASE4 · Chinese University of Hong Kong · NCT06727409
This study is testing a new combination of three medications to see if it can help people with type 2 diabetes and chronic kidney disease reduce protein in their urine.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06727409 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 2 diabetes and chronic kidney disease who are already on stable doses of SGLT2 inhibitors and ACE inhibitors or ARBs.
Not a fit: Patients with type 1 diabetes or those who have contraindications to the medications involved in the study may not benefit.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for managing kidney complications in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in using similar therapeutic combinations for managing diabetes and kidney disease, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Hong Kong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patients With Type 2 Diabetes, Finereone, Triple therapy, Type 2 Diabetes, Chronic kidney disease