Dapagliflozin in Living-Donor Kidney Transplant Recipients

NCT07555106 | Active Not Recruiting Phase 2

• 1 other identifier: R-2024-1301-159
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Transplant; Kidney Transplant Failure

Keywords

Dapagliflozin; Kidney transplant recipients; Kidney allograft function; Oxidative Stress; Graft Survival

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 12 months

• 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,

  Baseline to 12 months

Secondary Outcomes (25)

• Fibrosis

  12 months

• Acute Rejection

  12 months

• Blood Pressure

  Baseline, 3, 6 ,12 months

• Change in left ventricular ejection fraction (LVEF)

  Baseline to 12 months.

• Change in E/e' ratio

  Baseline to 12 months

Study Arms (2)

Dapagliflozin Group

EXPERIMENTAL

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

Drug: Dapagliflozin (10mg Tab)

Control Group

ACTIVE COMPARATOR

Standard post-transplant medical therapy without SGLT2 inhibitor.

Other: Standard of Care

Interventions

Dapagliflozin (10mg Tab) DRUG

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

Dapagliflozin Group

Standard of Care OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Guadalajara: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Universidad de Guadalajara

Guadalajara, Jalisco, 44250, Mexico

Location

Related Publications (4)

• 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.

  PMID: 41129246 BACKGROUND

• 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.

  PMID: 40892675 BACKGROUND

• 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.

  PMID: 37289399 BACKGROUND

• 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.

  PMID: 33855198 BACKGROUND

MeSH Terms

Interventions

dapagliflozin; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jorge Andrade Sierra, PhD

  Hospital de Especialidades del Centro Medico Nacional de Occidente IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 29, 2026
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)