Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Unity Health Toronto
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Adherence of Study Intervention
Study Overview
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.
Detailed Description
The proposed study is a parallel group, pilot randomized controlled trial. The trial will recruit 100 participants across Canadian hospitals and potentially others worldwide. We will recruit patients receiving maintenance dialysis for ≥ 90 days who have a background of type 2 diabetes mellitus. We will exclude patients with type 1 diabetes mellitus and recent recipients of a GLP-1-RA. Participants will be randomized 1:1 to either weekly subcutaneous semaglutide versus usual care and followed for 26 weeks. The key feasibility outcomes are: (1) successful recruitment of fully eligible patients (≥40%); (2) adherence to the study intervention (≥70% participants take at least 70% of prescribed study drug doses); and (3) completeness of follow-up (≥90% participants are successfully followed to 26 weeks). Secondary outcomes will include adverse events, major adverse cardiovascular events, changes in body weight, glycemic control, insulin dosage, blood pressure, lipid parameters, markers of CKD-related bone mineral disease, and quality of life.
As a pilot RCT, GUARD-1 will focus on the safety and tolerability of the GLP-1-RA semaglutide in the maintenance dialysis population. The key question of this trial is whether an RCT to evaluate the cardiovascular effects of GLP-1-RA in the maintenance dialysis population is feasible based on study recruitment, adherence, follow-up and safety.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Arms & Interventions
Semaglutide
Individuals randomized to this arm will take semaglutide once weekly.
Intervention: Semaglutide Pen (Drug)
Outcomes
Primary Outcomes
Adherence of Study Intervention
Time Frame: 26 weeks
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.
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](26 weeks)
- 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)
- Patient Reported Measures(26 weeks)