Dapagliflozin for Kidney Transplant Recipients with Diabetes

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

Recruiting Phase 4 Interventional Study
Kidney Transplant; Complications Vascular Diseases Diabetes
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for

This trial is looking for adults who have received a kidney transplant and have type 2 diabetes. Participants will take a medication called dapagliflozin to see if it helps with kidney and heart health.

Are You a Good Fit for This Trial?
Must be taking TacrolimusMycophenolate mofetilPrednisone
Must not be taking SGLT2 inhibitors
Rules you out Heart failureKidney disease

You may be able to join if

  • I am between 18 and 80 years old.
  • I had a kidney transplant at least 1 year ago.
  • I have type 2 diabetes or diabetes after my transplant.
  • I have stable blood pressure under 130/80 mm Hg.
  • I have stable diabetes management for at least 3 months.
  • I am taking specific medications for my kidney and blood pressure.
  • I can provide informed consent.

You may not be able to join if

  • I have type 1 diabetes.
  • I do not expect to live more than 1 year.
  • I have uncontrolled high blood pressure.
  • My hemoglobin A1c is over 9%.
  • My body mass index is over 40.
  • I have serious heart failure symptoms.
  • I am currently pregnant, planning to become pregnant, or breastfeeding.
  • I have a current urinary or urogenital infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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-transpla…
Trial Locations
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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 \<1…
Contacts

Jessica Kendrick

3037244837

Jessica.Kendrick@cuanschutz.edu

CONTACT

Petter Bjornstad

petter.bjornstad@cuanschutz.edu

CONTACT