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Implementation ResearchIMPLEMENT-CKDNCT07854808

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

An observational study of Implementation Research and Kidney Disease, run by The University of Queensland at 3 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Implementation of recommendations
How many people
1,390 participants
Where
3 sitesin 3 countries
Study dates
1 Jul 2027to 1 Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be recruited from Thailand, Fiji and Samoa.

Who may be able to join

  • People ≥ 18 years of age with one or more of the following:
  • chronic kidney disease (CKD) with eGFR > 20 mL/min/1.73m²;
  • type 2 diabetes mellitus (T2DM).

Who cannot join

  • Nil

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Rathika Krishnasamy contact

+61 401 696 408

implement-ckd@uq.edu.au

Laura Hickey contact

implement-ckd@uq.edu.au

3 sites in 3 countries

Fiji1 site

  • Ministry of Health, Fiji

    Suva

    Anis Ta'eed, implement-ckd@uq.edu.au

    Yogeshni Chandra

Samoa1 site

  • Department of Health, Samoa

    Apia

    Ben Matalavea, lbmatalavea@nkfs.ws

    Malama Tafuna'i

Thailand1 site

  • Chulalongkorn University

    Bangkok

    Talerngsak Kanjanabuch

Other trials in Thailand

About this study

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.

Read the 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.

Being tested
Implementation of recommendations
Keywords
implementation, kidney disease, chronic illness, cardiovascular disease
Medical subject headings
Kidney Diseases, Cardiovascular Diseases, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation of recommendationsOther

    The study will be organised into three periods:

    • A pre-implementation phase - co-design implementation strategies development in each region;
    • An implementation phase - initiation of SGT2i and evaluation;
    • A post-implementation phase - consolidate learnings and dissemination for scaling up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

Secondary outcomes (10)

  1. Adherence to SGLT2i therapy

    Patient reported uptake

    Measured: 24 months

  2. Effectiveness

    Rates of CKD detection

    Measured: 24 months

  3. Adoption

    % of participating centres that initiate implementation strategies.

    Measured: 24 months

  4. Implementation

    Acceptability and feasibility of implementation strategies. Fidelity to protocol

    Measured: 24 months

  5. Maintenance

    Score for the extent of normalisation of practice (Normalisation Measure Development tool)

    Measured: 24 months

  6. % initiation of other CKD management

    Measured: 24 months

  7. Effectiveness

    Rates of Kidney Failure

    Measured: 24 months

  8. Effectiveness

    Rates of CV Death

    Measured: 24 months

  9. Effectiveness

    Rates adverse drug reactions

    Measured: 24 months

  10. Effectiveness

    Rates all-cause hospitalisations

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2026
  2. Study start1 Jul 2027 (estimated)
  3. Primary completion1 Feb 2030 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07854808
Sponsor's protocol ID
25.01
Other IDs
APP2054344/GACDHS10
Acronym
IMPLEMENT-CKD
Status last verified
Aug 2026
First submitted
25 Aug 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Implementation Research and Kidney Disease, run by The University of Queensland at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Fiji, Samoa, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rathika Krishnasamy (+61 401 696 408, implement-ckd@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A Reach of 50% of eligible patients initiated on SGLT2i therapy (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07854808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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