Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis (GUARD-1)
Actively Recruiting
About This Study
GUARD-1 is a pilot randomized trial assessing the safety, tolerability, and feasibility of semaglutide use in adults with type 2 diabetes receiving maintenance dialysis for at least 90 days. Participants are randomized 1:1 to weekly subcutaneous semaglutide or usual care and followed for 26 weeks. The study evaluates recruitment, treatment adherence, and follow-up completeness to inform the feasibility of a larger cardiovascular outcomes trial, while also collecting safety and clinical outcomes.
Who Can Participate?
✓ 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