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Dapagliflozin for Kidney and Heart Health After Transplant

This study is testing dapagliflozin (a drug that helps your body remove sugar through urine) to see if it can improve kidney function and heart health in adults who have received a kidney transplant. You may be able to join if you are between 18 and 80 years old, had your kidney transplant at least a year ago, have certain kidney function levels (estimated glomerular filtration rate 30-90 ml/min/1.73m2), and have type 2 diabetes or diabetes that developed after your transplant. The main goal is to see how dapagliflozin affects albumin in your urine (a sign of kidney damage) after 12 months. The study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This is an interventional study, meaning participants will receive either dapagliflozin or a placebo (an inactive pill). It aims to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06140537

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

Recruiting
PHASE4Ages 18–80InterventionalTreatment
University of Colorado, Denver
~80 participants
Updated 2025-05-29 on ClinicalTrials.gov
What's tested:Dapagliflozin 10mg TabPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Albuminuria
Measured over Change from baseline to 12 months

Conditions

Kidney Transplant; Complications
Vascular Diseases
Diabetes

Explore related trials

Kidney TransplantationType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Colorado1

Who to contact

Jessica Kendrick
[email protected]
3037244837
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • AlbuminuriaChange from baseline to 12 months

    Measured by urine albumin to creatinine ratio