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NCT Number: NCT06140537

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

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.

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Key information

Conditions

Kidney Transplant; Complications Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Rachael Reddin

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin 10mg Tab

Drug

Dapagliflozin 10mg orally daily

Placebo

Drug

Placebo one tablet orally daily

Primary outcomes

  1. Albuminuria

    Time frame: Change from baseline to 12 months

    Measured by urine albumin to creatinine ratio

Secondary outcomes

  1. Kidney fibrosis

    Time frame: Change from baseline to 12 months

    Measured by Magnetic Resonance Imaging (MRI) and kidney biopsy tissue

  2. Kidney oxygenation

    Time frame: Change from baseline to 12 months

    Measured by MRI

  3. Arterial stiffness

    Time frame: Change from baseline to 12 months

    Measured by aortic pulse wave velocity

  4. Left ventricular mass

    Time frame: Change from baseline to 12 months

    measured by cardiac MRI

  5. estimated glomerular filtration rate

    Time frame: Change from baseline to 12 months

    estimated by CKD epi equation

  6. Kidney morphometry, metabolomics from paired kidney biopsies

    Time frame: Change from baseline to 12 months

    measured by single cell RNA sequencing from paired kidney biopsies

  7. safety and tolerability

    Time frame: baseline, 6 and 12 months

    assessed on basis of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Kendrick

CONTACT

[email protected]

3037244837

Petter Bjornstad

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2023
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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