Actively Recruiting
A Two Arm, Open Label, Pilot Study to Evaluate the Safety and Efficacy of the Combined Use of Once Daily 10mg Dapagliflozin and Once Weekly 1.0mg Semaglutide in Kidney Transplant Recipients
Led by University Health Network, Toronto · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the short-term effects, mechanisms, and safety of a 12-week combination treatment using dapagliflozin and semaglutide in 20 kidney transplant recipients (KTR), including those with and without type 2 diabetes. Kidney transplantation improves survival and quality of life in kidney failure patients, but options to protect the heart and kidney in transplant recipients are limited. This study focuses on how these two drugs, known to lower blood sugar and blood pressure and protect kidney function, work together in KTRs. Participants will first receive either semaglutide or dapagliflozin alone for 12 weeks. Semaglutide is given via weekly subcutaneous injections starting at 0.25 mg and increasing to 1 mg over 12 weeks, while dapagliflozin is taken as a daily 10 mg tablet. After this monotherapy phase, participants will receive both drugs combined for another 12 weeks. The study is open-label and randomized with two treatment arms. During the study, researchers will monitor kidney and heart function, blood pressure, liver stiffness, and salt and water removal. Safety will be assessed by tracking events like kidney injury, infections, and other side effects. Measurements will include kidney filtration rates, urine tests, blood sugar control, body composition, and arterial stiffness. Participants will be followed for a total of 24 weeks to evaluate changes from the start to the end of each treatment phase.
CONDITIONS
Brief 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
- Patients aged 6518 years with kidney transplant
- More than 3 months post kidney transplantation
- Estimated glomerular filtration rate (eGFR) 6520 ml/min/1.73m2
- Blood pressure between 90/60 and 160/100 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
- Need for kidney biopsy or rapid decline in eGFR within 30 days prior to screening
- Active BK, CMV, or EBV infection
- Recurrent pyelonephritis or need for 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
- Unstable diabetic retinopathy within 1 year prior to screening
- Use of SGLT2 inhibitors or GLP-1 receptor agonists within 30 days prior to screening
- Frequent episodes of hypoglycemia
- History of diabetic ketoacidosis requiring medical intervention or hospitalization
- Risk of volume depletion, hypotension, or electrolyte imbalance
- Known or suspected allergy to semaglutide or related products
- Unable to understand or comply with study requirements
- Any clinical condition that could jeopardize safety or affect study outcomes (e.g., immunocompromised status, active cancer, uncontrolled hypertension, cardiorenal or hepatorenal syndrome)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either semaglutide or dapagliflozin alone to evaluate the safety and efficacy of each drug.
Weekly visits for up to 12 weeks
Duration - 12 weeks
Participants receive a combination of semaglutide and dapagliflozin to assess the combined effect on kidney function and safety.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
Research Team
V
Vesta Lai
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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