NCT05938712RecruitingPhase 2
The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients
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
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 16 May 2023
- Start date
- Oct 2023
- Primary completion date
- Oct 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05938712
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From Oct 2023 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.).
Lab values
- Impending need for kidney biopsy or rapid decline in eGFR within 30 days prior to screening
Other
- 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.
Who the study is looking for
- 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%;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.