Combination therapy of two diabetes medications in kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the efficacy, mechanisms, and safety of a combination therapy using dapagliflozin, an SGLT2 inhibitor, and semaglutide, a GLP-1 receptor agonist, in kidney transplant recipients. Over a 24-week period, participants will receive dapagliflozin and semaglutide separately for the first 12 weeks, followed by a combination of both medications for the next 12 weeks. The study aims to assess various health parameters, including kidney function, blood pressure, and overall safety of the treatment in this specific patient population. The research is particularly focused on understanding how these medications can protect kidney function and improve cardiovascular health in transplant recipients.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Toronto General Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Sunita Singh, MD MSc FRCPC — University Health Network, Toronto General Hospital
• Study coordinator: Vesta Lai
• Email: vesta.lai@uhn.ca
• Phone: 416-340-4800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Supplemental vitamin A and nicotinamide for kidney transplant recipients at high risk of skin cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.