Recruiting
Phase 2

SGLT2 Inhibitor & GLP-1 Agonist

Sponsor:

University Health Network, Toronto

Code:

NCT05938712

Conditions

Kidney Transplant Recipients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin 10 MG

Semaglutide, 1.0 mg/mL

Study Details

Brief summary:

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

Kidney Transplant Recipients

Study ID

NCT05938712

Start date

Oct 24, 2023

Status verified date

Apr, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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
  • Actively treated 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 who plan to become pregnant whilst in the trial.
  • History of pancreatitis
  • Personal or family history or medullary thyroid cancer or MEN2B
  • History of unstable diabetic retinopathy within 1 year prior to screening
  • Use of SGLT2i or GLP-1RA within 30 days prior to screening.
  • Current and frequent episodes of hypoglycemia
  • Current history of DKA requiring medical intervention or hospitalization
  • With current risk of volume depletion, hypotension and/or electrolyte imbalance
  • With known or suspected hypersensitivity to semaglutide or related products
  • Patient not able to understand and comply with study requirements, based on Investigator's judgment.
  • 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.).

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide

Semaglutide Subcutaneous 0.25mg once weekly for 4 weeks, then 0.5mg once weekly for 4 weeks, then 1mg once weekly for 4 weeks.

experimental: Dapagliflozin

Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks

Interventions

Dapagliflozin 10 MG

Semaglutide subcutaneous once weekly for 12 weeks.

Semaglutide, 1.0 mg/mL

Dapagliflozin oral once daily for 12 weeks.

Primary outcome measure

  • Proximal tubular natriuresis with combination therapy [ Time Frame: From baseline to combination therapy end (24 weeks) ]
  • Proximal tubular natriuresis with monotherapy [ Time Frame: From baseline to monotherapy end (12 weeks) ]

Central Contacts and Locations

Central contacts

Vesta Lai

416-340-4800vesta.lai@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Vesta Lai

416-340-4800vesta.lai@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Type 2 diabetes
  • SGLT2 inhibition
  • GLP-1 receptor agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-01.