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Kidney TransplantPhase 2DAPA-GRAFTNCT07555106

Dapagliflozin in Living-Donor Kidney Transplant Recipients

A Phase 2 study testing Dapagliflozin (10mg Tab) in people with Kidney Transplant and Kidney Transplant Failure, run by University of Guadalajara at 1 site in Mexico.

Active, not recruiting

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

Official record
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Trial summary

This randomized, open-label, single-center clinical trial aims to evaluate the effect of dapagliflozin on kidney allograft function in adult recipients of a first living-donor kidney transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant, Kidney Transplant Failure
What is being tested?
Dapagliflozin (10mg Tab)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteMexico
Study dates
15 Sep 2024to 30 Sep 2026
Phase
Phase 2
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

  • Ability to provide written informed consent
  • Adult patients ≥18 years of age
  • First living-donor kidney transplant recipients
  • Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² at screening
  • Receiving standard immunosuppressive therapy (tacrolimus, mycophenolate mofetil, and prednisone) with induction therapy (thymoglobulin or basiliximab)

Who cannot join

  • Type 1 diabetes mellitus
  • Recipients of deceased donor kidney transplant
  • History of any other solid organ transplant
  • Second kidney transplant
  • Severe cardiovascular disease (congestive heart failure class IV, recent myocardial infarction, unstable angina, stroke, or transient ischemic attack within 8 weeks prior to enrollment)
  • HbA1c >12% in patients with diabetes mellitus
Show all 15Show fewer
  • Current use of SGLT2 inhibitors at enrollment
  • Known hypersensitivity or intolerance to SGLT2 inhibitors
  • Pregnant or breastfeeding women
  • Hepatic impairment (AST or ALT >3 times the upper limit of normal, or total bilirubin >2 times the upper limit of normal at enrollment)
  • Antibody-mediated rejection (AMR) or Banff grade ≥2A acute cellular rejection during the first week post-transplant
  • Use of anticoagulants, nonsteroidal anti-inflammatory drugs, pentoxifylline, or mineralocorticoid receptor antagonists (spironolactone, eplerenone, finerenone)
  • Highly sensitized recipients or presence of donor-specific antibodies prior to enrollment
  • Urological disorders (including recurrent urinary tract infections or urolithiasis within 12 months prior to enrollment) or severe genital infections
  • Presence of de novo or recurrent glomerulopathy or BK virus nephropathy during the first week post-transplant.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Universidad de Guadalajara

    Guadalajara, Jalisco, 44250

Other trials in Mexico

About this study

Official title: Effect of Dapagliflozin on Kidney Allograft Function in Living-Donor Kidney Transplant Recipients: A Randomized Open-Label Clinical Trial

This randomized, open-label, single-center clinical trial aims to evaluate the effect of dapagliflozin on kidney allograft function in adult recipients of a first living-donor kidney transplant. Participants will be randomized to receive dapagliflozin 10 mg daily starting 4 weeks after transplantation or standard care without SGLT2 inhibitor therapy. The primary outcomes include changes in estimated glomerular filtration rate (eGFR) and albuminuria over 12 months. Secondary outcomes include kidney graft histology findings, oxidative stress biomarkers, cardiovascular parameters, infectious events, and kidney graft survival at 12 months.

Read the detailed description

Kidney fibrosis is a major pathological mechanism associated with chronic kidney disease progression and kidney allograft dysfunction. Oxidative stress, mitochondrial dysfunction, inflammation, and tissue hypoxia have been implicated in the development of kidney fibrosis.

Sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors), including dapagliflozin, have demonstrated kidney-protective and cardiovascular benefits in patients with chronic kidney disease and type 2 diabetes. However, evidence in kidney transplant recipients remains limited, consisting mainly of small observational studies and fews randomized clinical trial.

This study evaluates whether dapagliflozin improves kidney allograft function, reduces albuminuria, modulates oxidative stress biomarkers, and influences kidney graft histological findings during the first year after living-donor kidney transplantation.

Being tested
Dapagliflozin (10mg Tab), Standard of Care
Keywords
Dapagliflozin, Kidney transplant recipients, Kidney allograft function, Oxidative Stress, Graft Survival

What participants receive

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

  • Dapagliflozin (10mg Tab)Drug

    Dapagliflozin 10 mg orally once daily administered in addition to standard immunosuppressive therapy for 12 months.

  • Standard of CareOther

    Participants receive standard immunosuppressive therapy and routine post-kidney transplant clinical management according to institutional protocols during the 12-month follow-up period.

Study groups in NCT07555106
Study groupRoleWhat they receive
Dapagliflozin GroupExperimentalDapagliflozin 10 mg orally once daily administered in addition to standard immunosuppressive therapy for 12 months.
Receives: Drug: Dapagliflozin (10mg Tab)
Control GroupActive comparatorStandard post-transplant medical therapy without SGLT2 inhibitor.
Receives: Other: Standard of Care

What is being measured

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

  1. Change in estimated glomerular filtration rate (eGFR)

    Change in estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI equation and expressed in mL/min/1.73 m².

    Measured: Baseline to 12 months

  2. Change in urinary albumin-to-creatinine ratio (UACR)

    Change in albuminuria assessed by urinary albumin-to-creatinine ratio (UACR) and expressed in mg/g, from baseline to 12 months,

    Measured: Baseline to 12 months

Secondary outcomes (25)

  1. Fibrosis

    Percentage of interstitial fibrosis on kidney allograft biopsy

    Measured: 12 months

  2. Acute Rejection

    Number of participants with biopsy-proven acute rejection

    Measured: 12 months

  3. Blood Pressure

    Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) using a calibrated sphygmomanometer during clinical visits.

    Measured: Baseline, 3, 6 ,12 months

  4. Change in left ventricular ejection fraction (LVEF)

    Left ventricular ejection fraction (LVEF), expressed as percentage (%), measured by transthoracic echocardiography using Simpson's biplane method.

    Measured: Baseline to 12 months.

  5. Change in E/e' ratio

    E/e' ratio measured by Doppler echocardiography as an estimate of left ventricular filling pressures.

    Measured: Baseline to 12 months

  6. Change in pulmonary artery systolic pressure (PASP)

    Pulmonary artery systolic pressure (PASP), expressed in mmHg, estimated by transthoracic echocardiography using tricuspid regurgitation velocity and standard echocardiographic methods.

    Measured: Baseline to 12 months

  7. Change in left ventricular mass index (LVMI)

    Left ventricular mass index (g/m²) measured by transthoracic echocardiography according to standardized guidelines.

    Measured: Baseline to 12 months

  8. Change in tricuspid annular plane systolic excursion (TAPSE)

    TAPSE, expressed in millimeters (mm), measured by M-mode echocardiography as an indicator of right ventricular systolic function

    Measured: Baseline to 12 months

  9. Change in left atrial volume index (LAVI)

    Left atrial volume index (LAVI), expressed in mL/m², measured by transthoracic echocardiography using the biplane area-length method.

    Measured: Baseline to 12 months

  10. Incidence of cardiovascular events

    Number of participants with cardiovascular events, including hospitalization for heart failure, myocardial infarction, or cardiovascular death.

    Measured: 12 months

  11. Urinary Tract Infections

    Number of participants with urinary tract infections

    Measured: 12 months

  12. Graft Survival

    Number of participants with graft survival at 12 months

    Measured: 12 months

  13. Hemoglobin

    Change in hemoglobin levels.expressed in g/dL .

    Measured: Baseline, 3, 6 , 12 months

  14. Hematocrit

    Change in hematocrit expressed as percentage (%).

    Measured: Baseline, 3, 6 and 12 months,

  15. Fasting Glucose

    Change in fasting plasma glucose levels expressed in mg/dL

    Measured: Baseline, 3, 6, 12 months,

  16. Change in HbA1c

    Change in glycated hemoglobin (HbA1c) from baseline, 6 and 12 months in participants with diabetes mellitus, expressed in percentaje.

    Measured: Baseline, 6 and 12 months

  17. Nitric Oxide

    Changes in nitric oxide levels from baseline to 12 months, expressed in µmol/L

    Measured: Baseline, 3 and 6 months.

  18. Lipid peroxidation

    Changes in lipid peroxidation expressed as malondialdehyde (MDA), nmol/mL.

    Measured: Baseline, 3 and 6 months

  19. Superoxide Dismutase Activity (SOD)

    Change in Superoxide Dismutase Activity (SOD) expressed in U/mL

    Measured: Baseline, 3, and 6 months

  20. Glutathione Peroxidase Activity (GPx)

    Change in Glutathione Peroxidase Activity (GPx), expressed as U/L.

    Measured: Baseline, 3 and 6 months

  21. Total Antioxidant Capacity (TAC)

    Change in Total antioxidant capacity (TAC) expressed as Units

    Measured: Baseline, 3 and 6 months

  22. 8-hydroxy-2'-deoxyguanosine (8-OHdG)

    Change in 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels from baseline to 12 months, expressed in ng/mL.

    Measured: Baseline, 3 and 6 months

  23. 8-oxoguanine glycosylase (OGG1)

    Change in 8-oxoguanine glycosylase (OGG1) levels from baseline to 12 months expressed in ng/mL.

    Measured: Baseline, 3 and 6 months

  24. Toll-like receptor 2 (TLR2)

    Changes in toll-like receptor 2 (TLR2)e xpressed in pg/mL

    Measured: Baseline, 3 and 6 months

  25. Toll-like receptor 2 (TLR4)

    Changes in toll-like receptor 2 (TLR4) expressed in pg/mL

    Measured: Baseline, 3 and 6 months

Timeline

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

  1. First posted29 Apr 2026
  2. Study start15 Sep 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment. Participants are randomized to receive dapagliflozin plus standard of care or standard of care alone, and outcomes are assessed prospectively over the follow-up period
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07555106
Sponsor's protocol ID
R-2024-1301-159
Acronym
DAPA-GRAFT
Status last verified
Apr 2026
First submitted
5 Mar 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be publicly shared to ensure participant confidentiality and comply with institutional and ethical data protection regulations. Study findings will be disseminated in aggregate form through scientific publications.

Publications

  • Novikova MS, Minushkina LO, Allazova SS, Zateyshchikov DA, Boeva OI, Kotenko ON, Vinogradov VE, Shilov EM, Antsiferov MB, Koteshkova OM, Molina LP. Efficacy and Safety of Sglt-2 Inhibitors In Renal Allograft Recipients: an Open-Label, Single-Center Prospective Study. Kardiologiia. 2025 Oct 23;65(9):10-18. doi: 10.18087/cardio.2025.9.n2952. English, Russian.

    PubMed 41129246

  • Demir ME, Helvaci O, Yildirim T, Merhametsiz O, Sezer S. Potential Role of SGLT-2 Inhibitors in Improving Allograft Function and Reducing Rejection in Kidney Transplantation. Clin Transplant. 2025 Sep;39(9):e70233. doi: 10.1111/ctr.70233.

    PubMed 40892675

  • Demir ME, Ozler TE, Merhametsiz O, Sozener U, Uyar M, Ercan Z, Bardak Demir S, Sezer S, Turkmen Sariyildiz G. The results of SGLT-2 inhibitors use in kidney transplantation: 1-year experiences from two centers. Int Urol Nephrol. 2023 Nov;55(11):2989-2999. doi: 10.1007/s11255-023-03645-7. Epub 2023 Jun 8.

    PubMed 37289399

  • Song CC, Brown A, Winstead R, Yakubu I, Demehin M, Kumar D, Gupta G. Early initiation of sodium-glucose linked transporter inhibitors (SGLT-2i) and associated metabolic and electrolyte outcomes in diabetic kidney transplant recipients. Endocrinol Diabetes Metab. 2020 Sep 13;4(2):e00185. doi: 10.1002/edm2.185. eCollection 2021 Apr.

    PubMed 33855198

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin (10mg Tab) in people with Kidney Transplant and Kidney Transplant Failure, run by University of Guadalajara at 1 site in Mexico.

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 5 inclusion and 15 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in estimated glomerular filtration rate (eGFR) (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. 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 NCT07555106, which also lists 4 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 29 Apr 2026.

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