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 takingTacrolimusMycophenolate mofetilPrednisone
Must not be takingSGLT2 inhibitors
Rules you outHeart 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.