Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis

Sponsor
Unity Health Toronto
Study ID
NCT07017270
Phase
PHASE4
Status
Recruiting

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 — DRUG
    Individuals 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

First listed
Jun 12, 2025
Start date
Nov 27, 2025
Status verified
Mar 2026
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 Group
    This treatment arm comprises a strategy of usual care for type 2 diabetes mellitus
  • Experimental: Semaglutide
    Individuals randomized to this arm will take semaglutide once weekly.

Primary Outcome Measure

Adherence of Study Intervention [ Time Frame: 26 weeks ]

Central Contacts

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