Actively Recruiting
The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients
Led by University Health Network, Toronto · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study aims to determine the short-term efficacy, mechanisms and safety of 12 weeks of dapagliflozin and semaglutide combination therapy in 20 KTR, with and without T2D.
CONDITIONS
Official Title
The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated written informed consent
- Age 18 years or older with kidney transplant
- More than 3 months since kidney transplantation
- Estimated glomerular filtration rate (eGFR) 20 ml/min/1.73m2 or higher
- Blood pressure less than 160/100 and greater than 90/60 mmHg at screening
- Body-mass index (BMI) between 18.5 and 40 kg/m2
- For patients with type 2 diabetes or post-transplant diabetes mellitus, HbA1c less than 12.0%
You will not qualify if you...
- Type 1 diabetes
- History of multi-organ transplant
- Acute coronary syndrome, transient ischemic attack, or stroke within 30 days prior to screening
- Impending need for kidney biopsy or rapid decline in eGFR within 30 days prior to screening
- Active treatment for BK, CMV, or EBV infection
- Recurrent pyelonephritis or need for indwelling or self-catheterization
- Prior amputation or ischemic rest pain
- Women who are pregnant, nursing, or planning pregnancy during the trial
- History of pancreatitis
- Personal or family history of medullary thyroid cancer or MEN2B
- History of unstable diabetic retinopathy within 1 year prior to screening
- Use of SGLT2 inhibitors or GLP-1 receptor agonists within 30 days prior to screening
- Current frequent episodes of hypoglycemia
- Current history of diabetic ketoacidosis requiring medical intervention or hospitalization
- Risk of volume depletion, low blood pressure, or electrolyte imbalance
- Known or suspected allergy to semaglutide or related products
- Inability to understand or comply with study requirements
- Any other clinical condition that may risk patient safety or affect study outcomes, including immunocompromised status, active malignancy, risk of infections, chronic viral infections, uncontrolled hypertension, or cardiorenal/hepatorenal syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
Research Team
V
Vesta Lai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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