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Can a diabetes drug protect the heart and kidneys in severe CKD?

NCT ID NCT05374291

Disease control Sponsor: University Medical Center Groningen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether dapagliflozin (Forxiga), a drug originally for diabetes, can reduce the risk of death, kidney failure, and heart failure hospitalization in 1750 people with severe chronic kidney disease. Unlike earlier studies, this trial includes patients on dialysis and those with a kidney transplant. Participants take either 10 mg of dapagliflozin or a placebo daily, and researchers will track outcomes over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin (Forxiga)
What this could lead to
If successful, this could provide a new treatment option to reduce the risk of death, kidney failure, and heart failure hospitalization in patients with severe chronic kidney disease, including those on dialysis or with a kidney transplant.
What could go wrong
This is a large Phase 3 trial, but previous studies excluded the sickest patients, so results may not be as strong here. There is also a risk of side effects like dehydration or infections, and the drug may not work as well in this advanced population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,750 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with advanced CKD i.e. an eGFR ≤25 mL/min/1.73m2 * Dialysis patients (at least 3 months after start of dialysis) * Transplant patients with an eGFR ≤45 mL/min/1.73m2 (at least 6 months after transplantation) In addition, to be eligible all subjects must meet all criteria below * Age \>18 years * Willing to sign informed consent * Pre-dialysis patients with eGFR ≤25 mL/min/1.73m2 have to be on a stable dose (no changes in dose or type of drug) of ACEis or ARBs for at least 4 weeks prior to the screening visit to be eligible to proceed to the randomization visit unless there is documented evidence that the patient does not tolerate an ACEi or ARB. These subjects will maintain their stable doses of ACEis or ARBs throughout the trial (when possible and tolerated by the patient). ACEi or ARBs are not required for patients on maintenance dialysis or kidney transplant recipients. Exclusion Criteria: * Mentally incapacitated subjects (i.e. not able to sign informed consent) * Diagnosis of type 1 diabetes mellitus * Concurrent treatment with SGLT2 inhibitor * History of ≥2 urinary tract / genital infections during the last six months * Life expectancy \<6 months in the opinion of the treating physician. * Scheduled start of dialysis within 3 months or kidney transplantation within 6 months * patients treated for a renal indication during the last 6 months with a course of systemic immunosuppressive agents or intensification of treatment with systemic immunosuppressive agents, such as patients with a kidney transplant and acute rejection or patients with GPA (Morbus Wegener) and a recent flare. * Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin. * History of severe hypersensitivity or known severe hepatic impairment (Child-Pugh class C) * History of severe noncompliance to medical regimens or unwillingness to comply with the study protocol. * Pregnancy or breastfeeding * Presence of other transplanted organ besides a kidney transplant * Severe lactose intolerance * Autosomal Dominant Polycystic Kidney Disease (ADPKD) treated with tolvaptan

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Death heart failure kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Death Heart failure Kidney disease, chronic Kidney failure Renal transplant failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    102 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Glorieux

    Ronse, Belgium

  • AZ Groeninge

    Kortrijk, Belgium

  • Admiraal de Ruyter Ziekenhuis

    Goes, Zeeland, Netherlands

  • Albert Schweitzer ziekenhuis

    Dordrecht, South Holland, Netherlands

  • Alrijne

    Leiderdorp, South Holland, Netherlands

  • Amphia Ziekenhuis

    Breda, North Brabant, Netherlands

  • Amsterdam UMC

    Amsterdam, North Holland, Netherlands

  • Bernhoven

    Uden, Netherlands

  • Box Hill Hospital (Eastern Health)

    Melbourne, Australia

  • Bravis ziekenhuis

    Roosendaal, Netherlands

  • Canberra Health Services

    Canberra, Australian Capital Teritory, Australia

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, Netherlands

  • Changi General Hospital

    Singapore, Singapore

  • Charité

    Berlin, 10117, Germany

  • Clínica Universidad de Navarra

    Pamplona, Spain

  • Concord Repatriation General Hospital

    Sydney, New South Wales, Australia

  • Deventer Ziekenhuis

    Deventer, Netherlands

  • Diakonessenhuis Utrecht

    Utrecht, Netherlands

  • Dialyse Centrum Groningen

    Groningen, Provincie Groningen, Netherlands

  • Dialysecentrum Dianet (Amsterdam)

    Amsterdam, Netherlands

  • Dialysecentrum Dianet (Utrecht)

    Utrecht, Netherlands

  • Dialysecentrum Tergooi

    Hilversum, Netherlands

  • Dialysezentrum Heilbronn - Überörtliche Berufsausübungsgemeinschaft für Nephro und Dialyse (ÜBAG)

    Heilbronn, 74076, Germany

  • East Metro Health Services (Royal Perth Hospital and Armadale Health Services)

    Perth, Western Australia, Australia

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, Netherlands

  • Flevoziekenhuis

    Almere Stad, Flevoland, Netherlands

  • Franciscus Gasthuis en Vlietland

    Rotterdam, Netherlands

  • Gelre Ziekenhuizen

    Apeldoorn, Gelderland, Netherlands

  • Haaglanden Medisch Centrum

    The Hague, South Holland, Netherlands

  • HagaZiekenhuis

    The Hague, South Holland, Netherlands

  • Hospital Arnau de Vilanova

    Lleida, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital Clínic Barcelona

    Barcelona, Spain

  • Hospital Son Llàtzer

    Palma de Mallorca, Spain

  • Hospital Universitari Dr Peset

    Valencia, Spain

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Isala Ziekenhuis

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Jessa Ziekenhuis

    Hasselt, Belgium

  • John Hunter Hospital

    New Lambton Heights, New South Wales, Australia

  • Laurentius Ziekenhuis

    Roermond, Limburg, Netherlands

  • Leiden UMC

    Leiden, Netherlands

  • Liverpool Hospital

    Sydney, New South Wales, Australia

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, Netherlands

  • Maastricht UMC+

    Maastricht, Netherlands

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, Netherlands

  • Meander Medisch Centrum

    Amersfoort, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Medizinische Klinik und Poliklinik I der Universitätsklinik WürzburgSchwerpunkt Nephrologie

    Würzburg, 697080, Germany

  • National University Hospital

    Singapore, Singapore

  • Nephrologisches Zentrum Villingen/Schwenningen

    Villingen-Schwenningen, 678052, Germany

  • Niercentrum aan de Amstel

    Amstelveen, Netherlands

  • Nierenzentrum Heidelberg

    Heidelberg, 69120, Germany

  • Nierenzentrum Wiesbaden

    Wiesbaden, 2365191, Germany

  • Noordwest Ziekenhuisgroep Alkmaar

    Alkmaar, Netherlands

  • OLVG

    Amsterdam, North Holland, Netherlands

  • Praxis für Dialyse und Nierenkrankheiten

    Berlin, 12627, Germany

  • Prince of Wales Hospital

    Sydney, New South Wales, Australia

  • Radboud UMC

    Nijmegen, Netherlands

  • Reinier de Graaf Ziekenhuis

    Delft, Netherlands

  • Royal Adelaide Hospital

    Adelaide, South Australia, Australia

  • Royal Brisbane and Womens Hospital

    Brisbane, Queensland, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, Australia

  • Royal North Shore Hospital

    Sydney, New South Wales, Australia

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, Australia

  • Saxenburgh Medisch Centrum

    Hardenberg, Overijssel, Netherlands

  • Sengkang General Hospital

    Singapore, Singapore

  • Singapore General Health

    Singapore, Singapore

  • Spaarne Gasthuis

    Hoofddorp, Netherlands

  • St George Hospital

    Sydney, New South Wales, Australia

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • St. Jansdal ziekenhuis

    Lelystad, Netherlands

  • Sunshine Coast Hospital and Health Services

    Birtinya, Queensland, Australia

  • Townsville University hospital

    Douglas, Queensland, Australia

  • UMC Utrecht

    Utrecht, Netherlands

  • UMCG

    Groningen, Provincie Groningen, Netherlands

  • UZ Antwerpen

    Antwerp, Belgium

  • UZ Brussel

    Brussels, Belgium

  • UZ Leuven

    Leuven, Belgium

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Halle (Saale) Innere Medizin 2

    Halle, 06120, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Universitätsklinikum JenaKlinik für Innere Medizin III

    Jena, 07747, Germany

  • Universitätsklinikum RegensburgAbteilung für Nephrologie

    Regensburg, 93053, Germany

  • Universitätsklinikum Tübingen Medizinische Klinik IV

    Tübingen, 72076, Germany

  • Universitätsklinikum Ulm, Klinik für Innere Medizin I, Nephrologie

    Ulm, 89081, Germany

  • Universitätsmedizin Mainz

    Mainz, 55131, Germany

  • Vall d'Hebron University Hospital

    Barcelona, Spain

  • VieCuri Medisch Centrum

    Venlo, Netherlands

  • Western Health

    Melbourne, Victoria, Australia

  • Westmead Hospital

    Sydney, New South Wales, Australia

  • Wilhelmina Ziekenhuis Assen

    Assen, Drenthe, Netherlands

  • Wollongong Hospital

    Wollongong, New South Wales, Australia

  • Zentrum fuer Nieren-, Hochdruck- und Stoffwechselerkrankungen Hannover

    Hanover, 30625, Germany

  • Ziekenhuisgroep Twente

    Almelo, Overijssel, Netherlands

  • Zuyderland Medisch Centrum

    Sittard, Limburg, Netherlands

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