ConditionKidney Transplant Recipient
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Semaglutide 3 MG [Rybelsus]
- Semaglutide 7 MG [Rybelsus]
- Semaglutide 14 MG [Rybelsus]
- Placebo Oral Tablet
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov