A Phase 4 interventional study of Dapagliflozin 10mg Tab and Placebo in Kidney Transplant; Complications, Vascular Diseases and Diabetes, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Treatment
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.
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's planned enrollment of 80 is close to the median of 78 across 639 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive dapagliflozin 10mg daily
Drug: Dapagliflozin 10mg Tab
Participants will receive one placebo tablet daily
Drug: Placebo
Dapagliflozin 10mg orally daily
Placebo one tablet orally daily
Albuminuria
Measured by urine albumin to creatinine ratio
Time frame: Change from baseline to 12 months
Kidney fibrosis
Measured by Magnetic Resonance Imaging (MRI) and kidney biopsy tissue
Time frame: Change from baseline to 12 months
Kidney oxygenation
Measured by MRI
Time frame: Change from baseline to 12 months
Arterial stiffness
Measured by aortic pulse wave velocity
Time frame: Change from baseline to 12 months
Left ventricular mass
measured by cardiac MRI
Time frame: Change from baseline to 12 months
estimated glomerular filtration rate
estimated by CKD epi equation
Time frame: Change from baseline to 12 months
Kidney morphometry, metabolomics from paired kidney biopsies
measured by single cell RNA sequencing from paired kidney biopsies
Time frame: Change from baseline to 12 months
safety and tolerability
assessed on basis of adverse events
Time frame: baseline, 6 and 12 months
Plan to share: Yes — At the conclusion of the study, data, which has been stripped of all personal identification information and coded with a number, will be made available to qualified individuals within the scientific community who apply for data use. The results and outcomes of this study will be made generally available by publication and journal articles submitted to PubMed Central in compliance with NIH access guidelines.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Colorado, Denver