Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
- Sponsor
- Unity Health Toronto
- Study ID
- NCT07017270
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Diabetes
- Dialysis
- End Stage Kidney Disease (ESRD)
- Kidney Disease, Chronic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide Pen — DRUGIndividuals randomized to this arm will take semaglutide once weekly. For participants receiving in-centre hemodialysis, the intervention may be administered during the dialysis session by nursing personnel based on the patient's preference.
Study Details
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.
Key Dates
- Start date
- Jul 31, 2025
- Status verified
- Apr 2025
- Primary completion
- Jul 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- No Intervention: Usual Care GroupThis treatment arm comprises a strategy of usual care for type 2 diabetes mellitus
- Experimental: SemaglutideIndividuals randomized to this arm will take semaglutide once weekly.
Primary Outcome Measure
Adherence of Study Intervention [ Time Frame: 26 weeks ]
Central Contacts
- Ron Wald, MD(416) 867-3703
- Kevin Yau, MD
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