Title: Trial Without Borders IMPLEMENT-CKD: IMPLEMENTation of Evidence-Based SGLT2i to Reduce Global Burden of Cardiovascular and Chronic Kidney Disease
Principal Investigators: Professor Rathika Krishnasamy
Clinical Project Manager: Laura Hickey
Clinical Research Associate: TBC
Trial Number: AKTN 25.01
Population: People aged ≥ 18 years with one or more of the following:
1) Chronic kidney disease (CKD) with eGFR >20 mL/min/1.73 m2
2) Type 2 diabetes (T2DM)
Primary outcome: To improve access to and uptake of SGLT2 inhibitors (SGLT2i), enabling people with CKD or type 2 diabetes to receive these life-saving medicines as part of routine care.
Status: In development
Target Recruitment: 1390 participants globally
Participating Sites:
| Site | Lead |
| Australia – AKTN Global Coordinating Centre | Professor Rathika Krishnasamy |
| Thailand | Professor Talerngsak Kanjanabuch |
| Fiji | Dr Yogeshni Chandra & Dr Anis Ta’eed |
| Samoa | Dr Ben Matalavea & Dr Malama Tafuna’i |
Funding: This project is funded by the Grant: 2025 NHMRC-GACD Strengthening Health Systems Application 2054344
Trial Summary
The IMPLEMENT-CKD project aims to improve access to and utilisation of SGLT2 inhibitor (SGLT2i) therapies across Thailand and Pacific Island countries. The study is being developed in close partnership with local communities, healthcare providers, and policymakers to ensure that it aligns with the unique needs and healthcare contexts of each region.
The project will be conducted in several phases. Initially, researchers will collaborate with local health systems to identify existing challenges, barriers, and opportunities related to SGLT2i use. Following this, tailored implementation strategies will be introduced to support healthcare professionals in initiating eligible patients on SGLT2i treatment. These strategies may include clinician education and training, workflow adaptations within clinics, and decision-support tools to guide prescribing.
In parallel, the study team will work with health ministries and key stakeholders to explore mechanisms for improving affordability and availability of SGLT2 inhibitors.
The effectiveness of the intervention will be evaluated through several outcomes. The primary implementation goal is to ensure that at least 50% of eligible patients are initiated on SGLT2i therapy. Additional outcomes will assess acceptability among healthcare providers and patients, fidelity and consistency of implementation, and sustainability within routine clinical practice.
The study will also examine downstream clinical outcomes using routinely collected health data, including reductions in kidney failure and cardiovascular mortality.
IMPLEMENT-CKD has the potential to significantly improve access to evidence-based therapies, leading to better health outcomes and longer lives for people with CKD and type 2 diabetes. Additionally, the project will strengthen health systems by enhancing care pathways, building workforce capability, and supporting improved management of chronic conditions such as diabetes and hypertension. Lessons learned from this study are expected to inform national policies and support scalable models of care in similar settings globally.