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
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Dapagliflozin; Semaglutide

Criteria

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.).