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

NCT06140537 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 23-1360
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Albuminuria

  Measured by urine albumin to creatinine ratio

  Change from baseline to 12 months

Secondary Outcomes (7)

• Kidney fibrosis

  Change from baseline to 12 months

• Kidney oxygenation

  Change from baseline to 12 months

• Arterial stiffness

  Change from baseline to 12 months

• Left ventricular mass

  Change from baseline to 12 months

• estimated glomerular filtration rate

  Change from baseline to 12 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Participants will receive dapagliflozin 10mg daily

Drug: Dapagliflozin 10mg Tab

Placebo

PLACEBO COMPARATOR

Participants will receive one placebo tablet daily

Drug: Placebo

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10mg orally daily

Dapagliflozin

Placebo DRUG

Placebo one tablet orally daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Vascular Diseases; Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jessica Kendrick

CONTACT

3037244837; Jessica.Kendrick@cuanschutz.edu

Petter Bjornstad

CONTACT

petter.bjornstad@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 20, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.

Locations

US (1)