RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-01
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06140537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-80 years
  2. * Kidney transplant received 1 year prior to randomization
  3. * estimated glomerular filtration rate 30-90 ml/min/1.73m2
  4. * Urine albumin to creatinine ratio (ACR) 30-5000 mg/g
  5. * Pre-existing type 2 diabetes or post-transplant diabetes mellitus
  6. * Blood pressure \<130/80 mm Hg prior to randomization
  7. * Able to provide informed consent
  8. * Stable immunosuppression for at least 3 months prior to baseline consisting of tacrolimus, mycophenolate mofetil/mycophenolic acid and prednisone
  9. * Stable anti-hypertensive regimen for at least 1month prior to baseline
  10. * Stable diabetes management for at least 3 months prior to baseline
  11. * Stable angiotensin converting enzyme inhibitor/angiotensin receptor blocker use for at least 3 months prior to baseline (if applicable)
  12. * Glucagon-like peptide-1 receptor agonist (GLP-1RA) for at least 3 months prior to baseline (if applicable)
  1. * Type 1 diabetes
  2. * Anticipated life expectancy \<1 year
  3. * Uncontrolled hypertension
  4. * Hemoglobin A1c \>9%
  5. * Body mass index \>40 kg/m2
  6. * New York Heart Association Class 3 or 4 heart failure symptoms, an EF ≤30%, or hospitalization for heart failure in the past 3 months
  7. * Pregnancy, plans to become pregnant, or breastfeeding
  8. * Current use of sodium glucose cotransporter-2 (SGLT2) inhibitors
  9. * Current urinary or urogenital infection
  10. * Use of anticoagulants (contraindication to kidney biopsy)
  11. * Magnetic resonance imaging (MRI) contraindications
  12. * History of lower-limb amputation irrespective of etiology
  13. * Known hypersensitivity to dapagliflozin

Contacts and Locations

Study Contact

Jessica Kendrick
CONTACT
3037244837
Jessica.Kendrick@cuanschutz.edu
Petter Bjornstad
CONTACT
petter.bjornstad@cuanschutz.edu

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Kidney Transplant; Complications
  • Vascular Diseases
  • Diabetes