Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
Recruiting · NCT07017270 · Interventional (participants receive a specific treatment) · Lead sponsor: Unity Health Toronto
View the official record on ClinicalTrials.gov →Interventions studied
Semaglutide Pen
What this trial is about
This study aims to determine if GLP1RA is safe and tolerable in maintenance dialysis population, adherence, and feasibility of a larger definitive cardiovascular outcome trial in this population. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥ 18
- Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days
- confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and/or insulin.
- Ability to provided informed consent or through their substitute decision maker
Exclusion criteria
- Type 1 DM
- Use of a GLP-1-RA within 30 days prior to screening
- Personal or first-degree relative(s) with a history of type 2 multiple endocrine neoplasia syndrome or medullary thyroid cancer, or acute pancreatitis (within 180 days of study screening)
- Confirmed pregnancy, women of childbearing potential
- Known hypersensitivity to GLP-1-RA
- Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months
- Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA
Where it is running
4 locations listed.
- Unity Health Toronto - Toronto, Ontario, Canada
- Unity Health Toronto - Toronto, Ontario, Canada
- Unity Health Toronto - Toronto, Ontario, Canada
- Unity Health Toronto - Toronto, Ontario, Canada