Recruiting

Dapagliflozin

Sponsor:

University of Colorado, Denver

Code:

NCT06140537

Conditions

Kidney Transplant; Complications

Vascular Diseases

Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin 10mg Tab

Placebo

Study Details

Brief summary:

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.

Conditions

Kidney Transplant; Complications

Vascular Diseases

Diabetes

Study ID

NCT06140537

Start date

Feb 1, 2024

Status verified date

May, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Oct 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dapagliflozin

Participants will receive dapagliflozin 10mg daily

placebo comparator: Placebo

Participants will receive one placebo tablet daily

Interventions

Dapagliflozin 10mg Tab

Dapagliflozin 10mg orally daily

Placebo

Placebo one tablet orally daily

Primary outcome measure

  • Albuminuria [ Time Frame: Change from baseline to 12 months ]

Central Contacts and Locations

Central contacts

Jessica Kendrick

3037244837Jessica.Kendrick@cuanschutz.edu

Petter Bjornstad

petter.bjornstad@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Rachael Reddin

Rachael.Reddin@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 29, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-05-29.