Trial Without Borders IMPLEMENT-CKD: IMPLEMENTation of Evidence-Based SGLT2i to Reduce Global Burden of Cardiovascular and Chronic Kidney Disease (IMPLEMENT-CKD)

Chronic kidney disease (CKD) affects millions, especially in low- and middle-income countries, where many die early due to lack of treatment. One group of medicines, called SGLT2 inhibitors (SGLT2i), have been shown to slow down kidney damage and reduce the risk of heart-related deaths. The IMPLEMENT-CKD project will work with communities in Thailand, Fiji and Samoa to make it easier for people with CKD or type 2 diabetes to get these life-saving medicines as part of their regular care.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Disease; Chronic Illness; Kidney Disease; Implementation Research
• Intervention / Treatment: Other: Implementation of recommendations

Detailed Description

Chronic kidney disease (CKD) affects over 850 million people globally, with 80% living in low- and middle-income countries (LMICs) where access to effective treatment is limited. Sodium-glucose co-transporter 2 inhibitors (SGLT2i), now listed on the WHO Essential Medicines List, have demonstrated significant benefits in slowing CKD progression and reducing cardiovascular mortality. The IMPLEMENT-CKD project is a co-designed, multi-phased, multi-country health systems strengthening initiative aimed at improving equitable access to and sustained use of SGLT2i in Thailand, and the Pacific Islands. The intervention is contextually tailored, prioritising stakeholder engagement, cultural adaptation, and scalable care models. A mixed-method, adaptive implementation study will be conducted in phases. The pre-implementation phase uses community-based participatory action research and knowledge co-creation to develop culturally relevant strategies. During implementation, clinical staff are trained to initiate SGLT2i therapy in eligible adults with CKD (eGFR >20 mL/min/1.73m²) or type 2 diabetes. Real-world delivery is supported by monthly prescribing audits and mobile surveys. Strategies are refined biannually using Plan-Do-Study-Act (PDSA) cycles. The scale-up phase engages stakeholders to advocate for national inclusion of SGLT2i through policy briefs and collaboration with professional bodies. The primary implementation outcome is 50% reach-defined as the proportion of eligible patients initiated on SGLT2i. Additional outcomes include adoption, fidelity, acceptability, and normalisation of practice. Health systems outcomes include changes in protocols, workforce capacity, medicine availability, and policy engagement. Clinical outcomes such as kidney failure and cardiovascular death will be monitored using routine data. The project aims to enhance CKD management, reduce disparities, and inform scalable, evidence-based policy for chronic disease care in LMICs.

• Study Type: Observational
• Enrollment (Estimated): 1390

Contacts and Locations

• Study Contact: Name: Rathika Krishnasamy; Phone Number: +61 401 696 408; Email: implement-ckd@uq.edu.au
• Study Contact Backup: Name: Laura Hickey; Email: implement-ckd@uq.edu.au

Study Locations

• Fiji
  • Suva, Fiji
    • Ministry of Health, Fiji
    • Contact: Anis Ta'eed; Email: implement-ckd@uq.edu.au
    • Contact: Yogeshni Chandra
• Samoa
  • Apia, Samoa
    • Department of Health, Samoa
    • Contact: Ben Matalavea; Email: lbmatalavea@nkfs.ws
    • Contact: Malama Tafuna'i
• Thailand
  • Bangkok, Thailand
    • Chulalongkorn University
    • Contact: Talerngsak Kanjanabuch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Thailand, Fiji and Samoa.

Description

Inclusion Criteria:

People ≥ 18 years of age with one or more of the following:

1. chronic kidney disease (CKD) with eGFR > 20 mL/min/1.73m²;
2. type 2 diabetes mellitus (T2DM).

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Design Details

• Observational Models: OTHER
• Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A Reach of 50% of eligible patients initiated on SGLT2i therapy	Proportion of eligible patients initiated on SGLT2i therapy, calculated as number of patients who were prescribed SGLT2i therapy during the intervention period/ number of patients meeting predefined eligibility criteria.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to SGLT2i therapy	Patient reported uptake	24 months
Effectiveness	Rates of CKD detection	24 months
Adoption	% of participating centres that initiate implementation strategies.	24 months
Implementation	Acceptability and feasibility of implementation strategies. Fidelity to protocol	24 months
Maintenance	Score for the extent of normalisation of practice (Normalisation Measure Development tool)	24 months
% initiation of other CKD management		24 months
Effectiveness	Rates of Kidney Failure	24 months
Effectiveness	Rates of CV Death	24 months
Effectiveness	Rates adverse drug reactions	24 months
Effectiveness	Rates all-cause hospitalisations	24 months

Collaborators and Investigators

• Sponsor: The University of Queensland
• Investigators: Principal Investigator: Rathika Krishnasamy, The University of Queensland

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: August 25, 2026
• First Submitted That Met QC Criteria: October 1, 2026
• First Posted (Actual): October 2, 2026

Study Record Updates

• Last Update Posted (Actual): October 2, 2026
• Last Update Submitted That Met QC Criteria: October 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: cardiovascular disease; kidney disease; chronic illness; implementation
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Kidney Diseases; Chronic Disease
• Other Study ID Numbers: 25.01; APP2054344/GACDHS10 (Other Grant/Funding Number: NHMRC-GACD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data sets will be made available by the Sponsor to researchers within the IMPLEMENT-CKD study for analysis of sub-studies after the primary manuscript has been accepted for publication.

For researchers outside the IMPLEMENT-CKD study, individual participant data will be made available upon request to a Data Access Committee, a review board set up to assess proposals based on sound science, benefit-risk balancing and research team expertise. Appropriate data will be made available to approved proposals. This process will be in effect for a period of 2 to 5 years following publication of the main study results. After 5 years, the data will be available in the Sponsor's data warehouse but without investigator support other than deposited metadata.

IPD Sharing Access Criteria

2 to 5 years following publication of the main study results.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No