Tests dapagliflozin with semaglutide in kidney transplant recipients
Tests two diabetes-related medicines together in kidney transplant recipients, with or without diabetes.
Key facts
- Who runs it
- University Health Network, Toronto
- Where
- Toronto, CanadaSee the site
- Trial code
- 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
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 20 people, planned
- Started
- 24 Oct 2023
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional, 2 groups
- Treatments tested
- Dapagliflozin 10 MG
- Semaglutide, 1.0 mg/mL
- Record updated
- 1 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a kidney transplant more than 3 months ago, with or without type 2 diabetes. It tests dapagliflozin and semaglutide together for 12 weeks.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Kidney transplant more than 3 months ago, with eGFR of 20 ml/min/1.73m2 or higher. Blood pressure below 160/100 and above 90/60. BMI between 18.5 and 40 kg/m2. People with type 2 diabetes or post-transplant diabetes need HbA1c below 12.0% (108 mmol/mol).
- Earlier treatment
- People who used an SGLT2 inhibitor or a GLP-1 receptor agonist in the 30 days before screening cannot join.
Main reasons for not taking part
- Type 1 diabetes
- More than one organ transplanted
- Pregnant, nursing, or planning pregnancy during the trial
- History of pancreatitis, or personal or family history of medullary thyroid cancer or MEN2B
- Treated BK, CMV or EBV infection, or recurrent pyelonephritis
This trial only enrols participants who have had an organ transplant. The registry sentence this rests on: Patients aged ≥18 years with KTR
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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%
Who cannot take part
- 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
Where in Canada
- Toronto General HospitalToronto, CanadaContact: Vesta LaiTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- SemaglutideTreatment being tested
Semaglutide Subcutaneous 0.25mg once weekly for 4 weeks, then 0.5mg once weekly for 4 weeks, then 1mg once weekly for 4 weeks.
Treatment: Dapagliflozin 10 MG and Semaglutide, 1.0 mg/mL
- DapagliflozinTreatment being tested
Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks
Treatment: Dapagliflozin 10 MG and Semaglutide, 1.0 mg/mL
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Tests dapagliflozin with semaglutide in kidney transplant recipientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 May 2026