RecruitingPhase 2NCT05938712

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


Sponsor

University Health Network, Toronto

Enrollment

20 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two diabetes/weight-loss medications — an SGLT2 inhibitor and a GLP-1 receptor agonist — to see if they can improve kidney function, blood sugar control, and weight in kidney transplant recipients. **You may be eligible if...** - You are 18 or older and have received a kidney transplant - It has been more than 3 months since your transplant - Your kidney is functioning at a moderate level (eGFR at least 20 ml/min) - Your blood pressure is within a manageable range - Your BMI is between 18.5 and 40 kg/m² - You have type 2 diabetes or are overweight with additional risk factors **You may NOT be eligible if...** - You have type 1 diabetes - You have very poor kidney function - You have had recent serious infections or other transplant complications - You are pregnant or planning to become pregnant - You have had recurrent urinary tract infections Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin 10 MG

Semaglutide subcutaneous once weekly for 12 weeks.

DRUGSemaglutide, 1.0 mg/mL

Dapagliflozin oral once daily for 12 weeks.


Locations(1)

Toronto General Hospital

Toronto, Ontario, Canada

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NCT05938712


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