Tests dapagliflozin with semaglutide in kidney transplant recipients
Tests two diabetes-related medicines together in kidney transplant recipients, with or without diabetes.
Plain-language title generated from the registry record
Registry title: The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- Toronto General HospitalToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Health Network, Toronto
- Trial code
- NCT05938712
- Record updated
- 1 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Signed and dated written informed consent; Patients aged ≥18 years with KTR; >3 months post kidney transplantation; Estimated glomerular filtration rate [eGFR] ≥20 ml/min/1.73m2; BP <160/100 and >90/60 at screening; Body-mass index [BMI] between 18.5-40kg/m2; In patients with T2D or PTDM, HbA1c <12.0%.
Exclusion: Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening; Prior amputation or ischemic rest pain; History of unstable diabetic retinopathy within 1 year prior to screening; Use of SGLT2i or GLP-1RA within 30 days prior to screening; Type 1 diabetes; History of multi-organ transplant; Actively treated BK, CMV or EBV infection; History of pancreatitis; Personal or family history or medullary thyroid cancer or MEN2B; Current history of DKA requiring medical intervention or hospitalization; With known or suspected hypersensitivity to semaglutide or related products; Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g. immunocompromised patients, active malignancy, patients who might be at higher risk of developing genital or mycotic infections, patients with chronic viral infections, uncontrolled hypertension, cardiorenal and/or hepatorenal syndrome etc.); Impending need for kidney biopsy or rapid decline in eGFR within 30 days prior to screening; Recurrent pyelonephritis or need for indwelling or self-catheterization; Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial; Current and frequent episodes of hypoglycemia; With current risk of volume depletion, hypotension and/or electrolyte imbalance; Patient not able to understand and comply with study requirements, based on Investigator's judgment.