Active — Not RecruitingPhase 2

Dapagliflozin in Living-Donor Kidney Transplant Recipients

Mexico54 participantsStarted 2024-09-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Inclusion Criteria: * 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) * Exclusion Criteria: * 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 di…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in estimated glomerular filtration rate (eGFR)

Timeframe: Baseline to 12 months

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

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT07555106

SponsorUniversity of Guadalajara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Kidney Transplant trials