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Kidney Disease, ChronicPhase 3NCT05374291

The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD

A Phase 3 study testing Dapagliflozin 10 mg/day (oral) in people with Kidney Disease, Chronic and Renal Transplant Failure, run by University Medical Center Groningen at 101 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dapagliflozin 10 mg/day (oral)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,750 participants
Where
101 sitesin 6 countries
Study dates
8 Nov 2022to Jul 2027
Phase
Phase 3
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

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

101 sites in 6 countries.

101 sites in 6 countries

Netherlands45 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch

  • Noordwest Ziekenhuisgroep Alkmaar

    Alkmaar

  • Ziekenhuisgroep Twente

    Almelo, Overijssel

  • Flevoziekenhuis

    Almere Stad, Flevoland

  • Meander Medisch Centrum

    Amersfoort

  • Niercentrum aan de Amstel

    Amstelveen

  • Amsterdam UMC

    Amsterdam, North Holland

  • OLVG

    Amsterdam, North Holland

  • Dialysecentrum Dianet (Amsterdam)

    Amsterdam

  • Gelre Ziekenhuizen

    Apeldoorn, Gelderland

  • Wilhelmina Ziekenhuis Assen

    Assen, Drenthe

  • Amphia Ziekenhuis

    Breda, North Brabant

  • Reinier de Graaf Ziekenhuis

    Delft

  • Deventer Ziekenhuis

    Deventer

  • Albert Schweitzer ziekenhuis

    Dordrecht, South Holland

  • Catharina Ziekenhuis Eindhoven

    Eindhoven

  • Maxima Medisch Centrum

    Eindhoven

  • Admiraal de Ruyter Ziekenhuis

    Goes, Zeeland

  • Dialyse Centrum Groningen

    Groningen, Provincie Groningen

  • UMCG

    Groningen, Provincie Groningen

  • Martini Ziekenhuis

    Groningen

  • Saxenburgh Medisch Centrum

    Hardenberg, Overijssel

  • Dialysecentrum Tergooi

    Hilversum

  • Spaarne Gasthuis

    Hoofddorp

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Leiden UMC

    Leiden

  • Alrijne

    Leiderdorp, South Holland

  • St. Jansdal ziekenhuis

    Lelystad

  • Maastricht UMC+

    Maastricht

  • St. Antonius Ziekenhuis

    Nieuwegein

  • Radboud UMC

    Nijmegen

  • Laurentius Ziekenhuis

    Roermond, Limburg

  • Bravis ziekenhuis

    Roosendaal

  • Erasmus Medisch Centrum

    Rotterdam, South Holland

  • Maasstad Ziekenhuis

    Rotterdam, South Holland

  • Franciscus Gasthuis en Vlietland

    Rotterdam

  • Zuyderland Medisch Centrum

    Sittard, Limburg

  • Haaglanden Medisch Centrum

    The Hague, South Holland

  • HagaZiekenhuis

    The Hague, South Holland

  • Bernhoven

    Uden

  • Diakonessenhuis Utrecht

    Utrecht

  • Dialysecentrum Dianet (Utrecht)

    Utrecht

  • UMC Utrecht

    Utrecht

  • VieCuri Medisch Centrum

    Venlo

  • Isala Ziekenhuis

    Zwolle

Other trials in Netherlands

Australia17 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Sunshine Coast Hospital and Health Services

    Birtinya, Queensland

  • Royal Brisbane and Womens Hospital

    Brisbane, Queensland

  • Canberra Health Services

    Canberra, Australian Capital Teritory

  • Townsville University hospital

    Douglas, Queensland

  • Western Health

    Melbourne, Victoria

  • John Hunter Hospital

    New Lambton Heights, New South Wales

  • Royal Melbourne Hospital

    Parkville, Victoria

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

    Perth, Western Australia

  • Concord Repatriation General Hospital

    Sydney, New South Wales

  • Liverpool Hospital

    Sydney, New South Wales

  • Prince of Wales Hospital

    Sydney, New South Wales

  • Royal North Shore Hospital

    Sydney, New South Wales

  • Royal Prince Alfred Hospital

    Sydney, New South Wales

  • St George Hospital

    Sydney, New South Wales

  • Westmead Hospital

    Sydney, New South Wales

  • Wollongong Hospital

    Wollongong, New South Wales

Other trials in Australia

Germany17 sites

  • Charité

    Berlin, 10117

  • Praxis für Dialyse und Nierenkrankheiten

    Berlin, 12627

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Halle (Saale) Innere Medizin 2

    Halle, 06120

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Zentrum fuer Nieren-, Hochdruck- und Stoffwechselerkrankungen Hannover

    Hanover, 30625

  • Nierenzentrum Heidelberg

    Heidelberg, 69120

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

    Heilbronn, 74076

  • Universitätsklinikum JenaKlinik für Innere Medizin III

    Jena, 07747

  • Universitätsmedizin Mainz

    Mainz, 55131

  • Universitätsklinikum RegensburgAbteilung für Nephrologie

    Regensburg, 93053

  • Universitätsklinikum Tübingen Medizinische Klinik IV

    Tübingen, 72076

  • Universitätsklinikum Ulm, Klinik für Innere Medizin I, Nephrologie

    Ulm, 89081

  • Nephrologisches Zentrum Villingen/Schwenningen

    Villingen-Schwenningen, 678052

  • Nierenzentrum Wiesbaden

    Wiesbaden, 2365191

  • Medizinische Klinik und Poliklinik I der Universitätsklinik WürzburgSchwerpunkt Nephrologie

    Würzburg, 697080

Other trials in Germany

Spain12 sites

  • Hospital Clínic Barcelona

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Universitari Germans Trias i Pujol

    Barcelona

  • Vall d'Hebron University Hospital

    Barcelona

  • Hospital Arnau de Vilanova

    Lleida

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Son Llàtzer

    Palma de Mallorca

  • Clínica Universidad de Navarra

    Pamplona

  • Hospital Clinico Universitario de Valencia

    Valencia

  • Hospital Universitari Dr Peset

    Valencia

Other trials in Spain

Belgium6 sites

  • UZ Antwerpen

    Antwerp

  • UZ Brussel

    Brussels

  • Jessa Ziekenhuis

    Hasselt

  • AZ Groeninge

    Kortrijk

  • UZ Leuven

    Leuven

  • AZ Glorieux

    Ronse

Other trials in Belgium

Singapore4 sites

  • Changi General Hospital

    Singapore

  • National University Hospital

    Singapore

  • Sengkang General Hospital

    Singapore

  • Singapore General Health

    Singapore

Other trials in Singapore

About this study

Official title: A Randomized Controlled Clinical Trial to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe Chronic Kidney Disease

Rationale:

Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs. SGLT2 inhibitors are clinically available since 2012 for the treatment of patients with diabetes mellitus type 2. Later, SGLT2 inhibitors appeared to have also specific reno- and cardioprotective effects. Remarkably, the trials that have been performed thus far excluded patients with an eGFR below 25 mL/min/1.73m2 at inclusion, prevalent dialysis patients, and kidney transplant recipients. This is unfortunate, because especially these patients are at high risk of reaching kidney failure requiring dialysis, cardiovascular complications and mortality, whereas there are only few proven effective therapies. There is emerging evidence from experimental studies and post hoc-analyses of randomized clinical trials that SGLT2 inhibitors may also be effective in preventing cardiovascular and mortality outcomes in these patients with severe CKD, including patients receiving dialysis or living with a kidney transplant. For instance, subgroup analysis of the DAPA-CKD trial comparing 624 patients with an eGFR<30 to the remainder of the trial population with better kidney function, demonstrated that the efficacy of the SGLT2 inhibitor dapagliflozin in reducing cardiovascular, heart failure and renal outcomes persisted in the population with impaired kidney function. Furthermore, in the DAPA-CKD trial patients continued to use dapagliflozin or placebo when dialysis was initiated. In the subgroup of patients who initiated dialysis, dapagliflozin was associated with a relative risk reduction for mortality of 21%. Finally, in kidney transplant recipients, SGLT2 inhibitors have been shown to be effective in lowering HbA1c, body weight, blood pressure and stabilize kidney function, and these agents were well tolerated and safe. Taken these findings together there is a sound rationale to study the long-term reno- and cardioprotective efficacy and safety of SGLT2 inhibitors in patients with severe CKD.

There are two cardiac sub-studies: the cardiac magnetic resonance imaging (MRI) sub-study and the echocardiography sub-study. The echocardiography sub-study is referred to as the "SGLT-2-inhibitors to Target Heart Failure in Peritoneal Dialysis" (STOP-HF-in-PD) study.

Read the detailed description

Objective:

To establish the reno- and cardioprotective efficacy and safety of dapagliflozin in patients with severe CKD

Study design:

Multicenter, randomized, controlled, double blinded, pragmatic, interventional trial

Study population:

  • Patients with advanced CKD, i.e. an eGFR ≤25 mL/min*1.73m2
  • Patients on dialysis (at least 3 months after start of dialysis)
  • Patients with a kidney transplant and an eGFR ≤45 mL/min/1.73m2 (at least 6 months after transplantation)

Intervention:

Dapagliflozin 10 mg/day or matching placebo

Primary outcome measure:

Combined endpoint of all-cause mortality, kidney failure, and hospitalization for heart failure in the overall study population

Study duration:

18 month recruitment phase, 30 month follow-up after enrollment of the last patient: Total study duration intended to last 48 months. It should be noted that the trial is event driven and will be terminated when 468 primary composite outcomes have occurred. The exact trial duration may therefore be shorter or longer than the intended 48 months.

Study visits:

Screening, baseline, week 2, month 3, month 6 and every 6 months thereafter. Information needed for the trial will be obtained as much as possible from visits taking place as part of routine clinical care.

Sample size:

Renal Lifecycle is designed as an endpoint driven trial and will finish when 468 primary study outcomes have occurred. The investigators have estimated a sample size of 1750-2000 patients.

Novel aspects:

A unique patient population with severe chronic kidney disease at very high risk of adverse outcomes for whom very few proven effective therapies exist. The initiation and efficacy of SGLT2 inhibitors, including dapagliflozin, has not been studied before in this population. However, SGLT2 inhibitors have the potential to be very effective and well tolerated which would imply a major advance in the pharmacotherapy of these patients.

When patients reach a renal endpoint, e.g. start or chronic dialysis or receiving a kidney transplantation, study medication will not be stopped as customary in many other trials in nephrology, but continued in the new phase of their "renal lifecycle", hence the name of the trial.

Sub studies:

Cardiac MRI sub-study The cardiac MRI sub-study will evaluate the effect of dapagliflozin on cardiac remodelling, as compared to placebo, measured with indexed left ventricular mass (LVMi), an intermediate cardiovascular outcome, in 250 participants across all three groups of the Renal Lifecycle Trial (i.e. advanced CKD, dialysis, kidney transplant recipients). This will provide robust evidence on the mechanisms under-pinning the cardioprotective effects of SGLT2 inhibitors in this high-risk patient population.

Primary outcome: Difference in LVMi after 12 months dapagliflozin compared to placebo.

Secondary outcomes: Differences between intervention groups in the following parameters at 12 months post-randomization: non-indexed LVM; indexed left atrial volume; non-indexed left atrial volume; indexed left and right ventricular end diastolic volume; indexed left and right ventricular end systolic volume; left and right ejection fraction.

Echocardiography sub-study (STOP-HF-in-PD) The echocardiography sub-study (STOP-HF-in-PD) will evaluate the effect of dapagliflozin on cardiac function, as compared to placebo, measured by left ventricular global longitudinal strain (LV-GLS), in 100 participants with kidney failure treated with peritoneal dialysis (PD). This will provide additional evidence on the mechanisms underlying the cardiac effects of SGLT2i in patients with kidney failure. Furthermore, the LV-GLS-data will be related to measured CKD- and PD-associated mediators of heart failure (measured in serum, urine and peritoneal effluent). This will aid to determine their relevance in patients with kidney failure, as well as to define if and to what extent SGLT2i affect these mediators in patients with kidney failure.

Primary outcome: Difference in LV-GLS after 6 months dapagliflozin compared to placebo.

Secondary and exploratory objectives: Differences between dapagliflozin compared to placebo after 6 and 12 months post-randomization for: LV-GLS; E/e'-ratio; left atrial volume index; left atrial strain; tricuspid velocity; left ventricular ejection fraction; LVMi; Physical functioning (6 minute walking test and KCCQ-12); 24h urine volume; residual kidney function; average daily ultrafiltration volume; peritoneal glucose exposure; peritoneal membrane characteristics.

Combined Cardiac Imaging Sub-studies A subset of participants enrolled in the echocardiography sub-study will also participate in the cardiac MRI sub-study, allowing for a combined evaluation of both imaging modalities. The aim is to evaluate the use of echocardiography and cardiac MRI as a tool to identify patients at highest risk for heart failure and those who may benefit from SGLT2i-induced cardio-protection.

Secondary outcomes: Association between change in LV-GLS and change in LVMi from baseline to 12-months across intervention groups; association between change in LV-GLS at 6 months and change in LVMi at 12 months across intervention groups.

Cognitive sub-study Patients with chronic kidney disease (CKD) are at a much higher risk for developing cognitive impairment compared with the general population and both lower glomerular filtration rate and the presence of albuminuria are associated with its development. SGLT-2 inhibitor use is associated with better preservation of cognitive function in patients with CKD including those on hemodialysis and after kidney transplantation compared to placebo.Patients will be requested to perform the symbol digit modalities test at the same time as the questionnaires, i.e. at baseline (visit 2), visit 5 and visit 6, once every year after visit 6 and at EoT/EET.The primary outcome of the cognition sub study is the change over time in the number of correct answers in the symbol digit modalities test within 90 seconds.

Kidney metabolism substudy The primary aim of this substudy is to evaluate the effect of dapagliflozin 10 mg compared to a placebo on energy metabolism assessed by changes in the renal mitochondrial oxidative phosphorylation capacity in kidney transplant recipients participating in the RENAL LIFECYCLE Trial at the 3-month Follow-up Visit. Further aims of this substudy are to evaluate the differences in metabolic substrate preferences by measuring ketone body or acylcarnitine substrate-driven mitochondrial respiration following the randomization to dapagliflozin or placebo.

Differences in mitochondrial architecture including mitochondrial quantity and morphology will be assessed using electron microscopy.

Being tested
Dapagliflozin 10 mg/day (oral), Placebo
Keywords
advanced CKD, dialysis, kidney transplant, all-cause mortality, kidney failure, hospitalization for heart failure, Dapagliflozin
Medical subject headings
Renal Insufficiency, Chronic, Heart Failure, Renal Insufficiency, Death

What participants receive

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

  • Dapagliflozin 10 mg/day (oral)Drug

    Also called Forxiga

    Patients take 10 mg dapagliflozin or matching placebo once daily in the morning

  • PlaceboDrug

    Patients take 10 mg dapagliflozin or matching placebo once daily in the morning

Study groups in NCT05374291
Study groupRoleWhat they receive
DapagliflozinExperimentalDapagliflozin 10 mg/day (oral)
Receives: Drug: Dapagliflozin 10 mg/day (oral)
PlaceboPlacebo comparatorPlacebo 10 mg/day (oral)
Receives: Drug: Placebo

What is being measured

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

  1. Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure

    To determine whether dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint

    Combined endpoint of all-cause mortality, kidney failure, and hospitalization for heart failure in the overall study population

    Measured: Total study duration intended to last 48 months

Secondary outcomes (4)

  1. Number of participants to reach all-cause mortality

    To determine if dapagliflozin is superior to placebo in reducing the incidence of all-cause mortality

    Measured: Total study duration intended to last 48 months

  2. Incidence of hospitalization for heart failure

    Incidence of hospitalization for heart failureTo determine if dapagliflozin is superior to placebo in reducing the incidence of heart failure

    Measured: Total study duration intended to last 48 months

  3. Incidence of kidney failure (chronic dialysis, kidney transplantation or mortality due to kidney failure)

    To determine if dapagliflozin is superior to placebo in reducing the incidence of kidney failure

    Measured: Total study duration intended to last 48 months

  4. incidence of the composite outcome (kidney failure, hospitalization for heart failure, and all-cause mortality) in subgroups

    To determine whether dapagliflozin is superior to placebo in reducing the incidence of the composite outcome in subgroups

    subgroups: advanced CKD i.e. an eGFR ≤30 mL/min/1.73m2, dialysis patients and transplant patients

    Measured: Total study duration intended to last 48 months

Timeline

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

  1. First posted16 May 2022
  2. Study start8 Nov 2022
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The RENAL LIFECYCLE trial consists of a screening period and a double blind treatment period with two arms. Participants will be randomly assigned in a 1:1 ratio to double blind treatment with dapagliflozin 10 mg/d or matching placebo. Randomization will be stratified by enrolment stratum (pre-dialysis, dialysis, kidney transplantation), centre and type 2 diabetes mellitus status yes/no) to ensure balanced distribution across the two treatment arms.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374291
Sponsor's protocol ID
202100617
Other IDs
2021-005446-15, 2023-508389-13-00, 2023
Status last verified
Oct 2026
First submitted
22 Apr 2022
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bakker WM, Heerspink HJL, Berger SP, Wanner C, Badve SV, Arnott C, Abrahams AC, van den Born JC, van Faassen TC, Gaillard CAJM, Gelens MACJ, Gorris JL, Hemmelder MH, Jakulj L, van Kruijsdijk RCM, Kuypers DRJ, van der Meer P, van der Net JB, Nijmeijer HH, Vervloet MG, de Vries APJ, Walsh M, Wang AY, Gansevoort RT; Renal Lifecycle Trial Investigators. Rationale and design of the Renal Lifecycle trial assessing the effect of dapagliflozin on cardiorenal outcomes in severe chronic kidney disease. Nephrol Dial Transplant. 2025 Aug 29;40(9):1746-1755. doi: 10.1093/ndt/gfaf046.

    PubMed 40053493

  • Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.

    PubMed 30990260

  • Heerspink HJL, Jongs N, Chertow GM, Langkilde AM, McMurray JJV, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Greene T; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on the rate of decline in kidney function in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):743-754. doi: 10.1016/S2213-8587(21)00242-4. Epub 2021 Oct 4.

    PubMed 34619108

  • Chertow GM, Vart P, Jongs N, Toto RD, Gorriz JL, Hou FF, McMurray JJV, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Langkilde AM, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of Dapagliflozin in Stage 4 Chronic Kidney Disease. J Am Soc Nephrol. 2021 Sep;32(9):2352-2361. doi: 10.1681/ASN.2021020167. Epub 2021 Jul 16.

    PubMed 34272327

  • Chewcharat A, Prasitlumkum N, Thongprayoon C, Bathini T, Medaura J, Vallabhajosyula S, Cheungpasitporn W. Efficacy and Safety of SGLT-2 Inhibitors for Treatment of Diabetes Mellitus among Kidney Transplant Patients: A Systematic Review and Meta-Analysis. Med Sci (Basel). 2020 Nov 17;8(4):47. doi: 10.3390/medsci8040047.

    PubMed 33213078

  • Combe C, Alencar de Pinho N, Guedes M, Frimat L, Fouque D, Liabeuf S, Niang A, Kanjanabuch T, Stengel B, Massy ZA, Pecoits-Filho R. Optimal patient care in advanced chronic kidney disease progressing to kidney failure. Nat Rev Nephrol. 2026 Jun;22(6):406-421. doi: 10.1038/s41581-026-01056-2. Epub 2026 Feb 10.

    PubMed 41667648

  • Karsten M, Badve SV, Gansevoort RT, Berger SP, Heerspink HJL, Abrahams AC, Billot L, Bon RHACM, Gelens MACJ, Guinness D, Hamilton-Craig C, van Heerebeek L, Hemmelder MH, Houston L, Kozor R, Kuypers DRJ, Monaghan H, Neal B, Neuen BL, Otton J, Perkovic V, Rajwani A, Wang AY, Vervloet MG, Arnott C, Jakulj L; Renal Lifecycle Trial Cardiac Imaging Sub-studies Investigators. Cardiac impact of dapagliflozin in advanced chronic kidney disease: rationale and design of the Renal Lifecycle Trial cardiac imaging sub-studies. Clin Kidney J. 2025 Dec 2;19(1):sfaf376. doi: 10.1093/ckj/sfaf376. eCollection 2026 Jan.

    PubMed 41551843

  • Horowitz A, Heeger P. Natural killer cells in kidney immune surveillance, injury and fibrosis. Nat Rev Nephrol. 2026 Mar;22(3):215-228. doi: 10.1038/s41581-025-01029-x. Epub 2025 Nov 28.

    PubMed 41315742

  • Garcia-Cosio Carmena MD, Farrero M, Blasco Peiro MT, Crespo M, Delgado Jimenez J, Diaz Molina B, Fernandez Rivera C, Garrido Bravo IP, Lopez Jimenez V, Melilli E, Mirabet Perez S, Perez Tamajon ML, Rangel Sousa D, Rodrigo E, Cruzado JM, Hernandez Marrero D; Spanish Society of Transplantation, the Spanish Society of Nephrology, and the Spanish Society of Cardiology (SET-SEC-SEN). Management of Kidney Disease in Heart Transplant Patients: A National Delphi Survey-based Consensus Expert Paper. Transplantation. 2025 Sep 1;109(9):e431-e445. doi: 10.1097/TP.0000000000005302. Epub 2025 Feb 7.

    PubMed 39928546

  • Gill M, Leung M, Luo CY, Cheung C, Beauchesne A, Chang D, Lan J, Johnston O. Erythrocytosis and thrombotic events in kidney transplant recipients prescribed a sodium glucose cotransport-2 inhibitor. Clin Transplant. 2023 Aug;37(8):e15013. doi: 10.1111/ctr.15013. Epub 2023 May 11.

    PubMed 37170711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin 10 mg/day (oral) in people with Kidney Disease, Chronic and Renal Transplant Failure, run by University Medical Center Groningen at 101 sites in 6 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 7 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 8 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 101 sites in Netherlands, Australia, Germany, Spain, Belgium and 1 more country. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure (time frame: Total study duration intended to last 48 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 NCT05374291, which also lists 10 linked publications.

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 8 Oct 2026.

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