Status:
NOT_YET_RECRUITING
Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Lead Sponsor:
University Health Network, Toronto
Conditions:
Kidney Transplant Recipient
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of placebo and semaglutide therapy in 74 KTR at risk of post-transplant diabetes mellitus (PTDM).
Detailed Description
A kidney transplant is the best treatment for people living with kidney failure as it allows people to live longer with a better quality of life. However, one in four kidney transplant recipients will...
Eligibility Criteria
Inclusion
- Signed and dated written informed consent.
- Adult (≥18 years) recipients of a living or deceased donor kidney transplant
- Between 4- and 12-weeks post kidney transplant
- Stable kidney function defined as an eGFR \> 30 ml/min/1.73m2 (CKD-EPI)
- At risk for PTDM at the time of transplant based on the following criteria:
- BMI ≥ 25 kg/m2, or
- Fasting plasma glucose 6.1-6.9 mmol/L (impaired fasting glucose), or
- 2hr OGTT plasma glucose 7.8-11.0 (impaired glucose tolerance), or
- HbA1C 5.5-6.4% (at risk for DM or prediabetes).
Exclusion
- Established diagnosis of type 1 or type 2 DM as per Diabetes Canada (including the need for glucose-lowering therapy for hyperglycemia at the time of screening)
- Kidney-Pancreas transplant recipient
- Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening
- History of pancreatitis
- Personal or family history of medullary thyroid cancer or MEN2B
- Women who are pregnant, nursing or plan on becoming pregnant whilst in the trial
- Use of GLP1RA in the 30 days prior to screening
- Contraindication to MRI (applicable only to those undergoing the optional MRI assessments)
- 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 outcom
- History of glucose-galactose malabsorption syndrome
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06913023
Start Date
January 5 2026
End Date
November 30 2027
Last Update
April 6 2025
Active Locations (2)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2