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

NCT ID: NCT06140537

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Kidney Transplant; Complications; Vascular Diseases; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dapagliflozin

Participants will receive dapagliflozin 10mg daily

Group Type: EXPERIMENTAL

Dapagliflozin 10mg Tab

Intervention Type: DRUG

Dapagliflozin 10mg orally daily

Placebo

Participants will receive one placebo tablet daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo one tablet orally daily

Interventions

Dapagliflozin 10mg Tab

Dapagliflozin 10mg orally daily

Intervention Type: DRUG

Placebo

Placebo one tablet orally daily

Intervention Type: DRUG

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 <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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Kendrick

Role: CONTACT

Jessica.Kendrick@cuanschutz.edu

3037244837

Petter Bjornstad

Role: CONTACT

petter.bjornstad@cuanschutz.edu

Facility Contacts

Rachael Reddin

Role: primary

Rachael.Reddin@cuanschutz.edu

Other Identifiers

23-1360

Identifier Type: -

Identifier Source: org_study_id