Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide Pen.
- Who it may be relevant to
- Registry conditions: Kidney Disease, Chronic, Diabetes, Dialysis, End Stage Kidney Disease (ESRD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Semaglutide Pen
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.
Primary outcome measures
- Adherence of Study Intervention [Time frame: 26 weeks]
Secondary outcome measures (6)
- Study Medication Discontinuation [Time frame: 26 weeks]
- Feasibility of Study Recruitment [Time frame: 26 weeks]
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 26 weeks]
- Major Adverse Cardiovascular Events [Time frame: 26 weeks]
- Follow Up Percentage at 26 weeks [Time frame: 26 weeks]
- Patient Reported Measures [Time frame: 26 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Unity Health Toronto — Toronto
- Unity Health Toronto — Toronto
Identifiers
NCT: NCT07017270 · CTO5185