The study aims to determine the short-term efficacy, mechanisms and safety of 24 weeks of semaglutide therapy in 37 KTR at risk of post-transplant diabetes mellitus (PTDM).
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)
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
Single group
Semaglutide 0.25 mg
DrugSubcutaneous semaglutide 0.25mg for 4 weeks.
Semaglutide 0.5 mg
DrugSubcutaneous semaglutide 0.5mg for 4 weeks.
Semaglutide 1.0 mg
DrugSubcutaneous semaglutide 1.0 mg for 4 weeks.
Semaglutide 1.7mg subcutaneous
DrugSubcutaneous semaglutide 1.7 mg for 4 weeks
Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY]
DrugSubcutaneous semaglutide 2.4 mg for 8 weeks
2-hour OGTT
The primary outcome of this study is the change in plasma glucose at 120 minutes following a 75g oral glucose challenge (2-hour OGTT) at 24 weeks. The 2-hour OGTT was selected as the primarily outcome in this study for the following reasons: 1) In selecting a surrogate outcome for PTDM in KTR, there are limitations to HbA1c and fasting glucose in this population; 2) The 2-hour OGTT is the recommended test for the diagnosis of PTDM in KTR and 3) The use of OGTT has been used in other PTDM prevention studies.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
: The side effects of GLP-1RA have been well described and will be assessed at each study visit. Adverse events include AKI, hypoglycemia, volume depletion, GI intolerance, amputations, pancreatitis, hepatobiliary complications and injection site or allergic reactions, infectious complications (any source), and malignancy. Episodes of biopsy-proven acute rejection (as defined by the Banff criteria), death-censored graft failure (defined as the need for initiation of chronic dialysis or re-transplantation) or death with graft function (defined as death with a functioning allograft) will also be collected. Kidney transplantation assures complete denervation of the transplanted kidney and the renal vasoconstrictive response in the setting of intravascular volume depletion is diminished in KTR. Therefore, frequent monitoring for adverse events has been integrated in our study design, occurring on 10 separate occasions, to capture these adverse events should they occur.
Estimated GFR
Calculated by CKD-EPI 2021 equation
Change in fasting blood glucose
GFR
Measured using 24-urine collection for creatinine, standardized per 1.73m2 body surface area. And estimated using CKD-EPI 2021 equation.
Change in kidney oxygenation (R2*)
Assessed via multiparametric kidney MRI in an optional cohort.
Change in kidney fibrosis (ADC)
Assessed via multiparametric kidney MRI in an optional cohort.
Change in kidney perfusion
Assessed via multiparametric kidney MRI in an optional cohort.
Change in kidney volume
Assessed via multiparametric kidney MRI in an optional cohort.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
