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Recruiting NCT06140537

Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients

Phase IV Interventional Kidney Transplant; Complications Vascular Diseases Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapagliflozin 10mg Tab, Placebo.
Who it may be relevant to
Registry conditions: Kidney Transplant; Complications, Vascular Diseases, Diabetes. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.

Interventions

  • Drug Dapagliflozin 10mg Tab
    Dapagliflozin 10mg orally daily
  • Drug Placebo
    Placebo one tablet orally daily

Primary outcome measures

  • Albuminuria [Time frame: Change from baseline to 12 months]
Secondary outcome measures (7)
  • Kidney fibrosis [Time frame: Change from baseline to 12 months]
  • Kidney oxygenation [Time frame: Change from baseline to 12 months]
  • Arterial stiffness [Time frame: Change from baseline to 12 months]
  • Left ventricular mass [Time frame: Change from baseline to 12 months]
  • estimated glomerular filtration rate [Time frame: Change from baseline to 12 months]
  • Kidney morphometry, metabolomics from paired kidney biopsies [Time frame: Change from baseline to 12 months]
  • safety and tolerability [Time frame: baseline, 6 and 12 months]

Eligibility criteria

Inclusion criteria

  • Age 18-80 years
  • Kidney transplant received 1 year prior to randomization
  • estimated glomerular filtration rate 30-90 ml/min/1.73m2
  • Urine albumin to creatinine ratio (ACR) 30-5000 mg/g
  • Pre-existing type 2 diabetes or post-transplant diabetes mellitus
  • Blood pressure <130/80 mm Hg prior to randomization
  • Able to provide informed consent
  • Stable immunosuppression for at least 3 months prior to baseline consisting of tacrolimus, mycophenolate mofetil/mycophenolic acid and prednisone
  • Stable anti-hypertensive regimen for at least 1month prior to baseline
  • Stable diabetes management for at least 3 months prior to baseline
  • Stable angiotensin converting enzyme inhibitor/angiotensin receptor blocker use for at least 3 months prior to baseline (if applicable)
  • Glucagon-like peptide-1 receptor agonist (GLP-1RA) for at least 3 months prior to baseline (if applicable)

Exclusion criteria

  • Type 1 diabetes
  • Anticipated life expectancy <1 year
  • Uncontrolled hypertension
  • Hemoglobin A1c >9%
  • Body mass index >40 kg/m2
  • New York Heart Association Class 3 or 4 heart failure symptoms, an EF ≤30%, or hospitalization for heart failure in the past 3 months
  • Pregnancy, plans to become pregnant, or breastfeeding
  • Current use of sodium glucose cotransporter-2 (SGLT2) inhibitors
  • Current urinary or urogenital infection
  • Use of anticoagulants (contraindication to kidney biopsy)
  • Magnetic resonance imaging (MRI) contraindications
  • History of lower-limb amputation irrespective of etiology
  • Known hypersensitivity to dapagliflozin

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT06140537 · 23-1360

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗