Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
GUARD-1
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2025
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
June 12, 2025
April 1, 2025
2 years
April 24, 2025
June 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence of Study Intervention
This will be determined if ≥ 70% of enrolled number of eligible participants (who are randomized) are adherent to the study intervention over the 26-week follow-up period.
26 weeks
Secondary Outcomes (6)
Study Medication Discontinuation
26 weeks
Feasibility of Study Recruitment
26 weeks
Safety Events of Special Interest
26 weeks
Major Adverse Cardiovascular Events
26 weeks
Follow Up Percentage at 26 weeks
26 weeks
- +1 more secondary outcomes
Study Arms (2)
Usual Care Group
NO INTERVENTIONThis treatment arm comprises a strategy of usual care for type 2 diabetes mellitus
Semaglutide
EXPERIMENTALIndividuals randomized to this arm will take semaglutide once weekly.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unity Health Toronto
Toronto, Ontario, M5B1W8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2025
First Posted
June 12, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
June 12, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share