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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Colorado, Denver

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-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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Type 1 diabetes

Anticipated life expectancy <1 year

Uncontrolled hypertension

Hemoglobin A1c >9%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10mg Tab

    Drug

    Dapagliflozin 10mg orally daily

  • Placebo

    Drug

    Placebo one tablet orally daily

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: DapagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Albuminuria

Measured by urine albumin to creatinine ratio

Time frame
Change from baseline to 12 months

Secondary outcomes

1

Kidney fibrosis

Measured by Magnetic Resonance Imaging (MRI) and kidney biopsy tissue

Time frame
Change from baseline to 12 months
2

Kidney oxygenation

Measured by MRI

Time frame
Change from baseline to 12 months
3

Arterial stiffness

Measured by aortic pulse wave velocity

Time frame
Change from baseline to 12 months
4

Left ventricular mass

measured by cardiac MRI

Time frame
Change from baseline to 12 months

Other outcomes

Sponsors and contacts

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