Kidney Disease, ChronicPhase 4GUARD-1NCT07017270
Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
A Phase 4 study testing Semaglutide Pen in people with Kidney Disease, Chronic and Diabetes, run by Unity Health Toronto at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Chronic, Diabetes, Dialysis
- What is being tested?
- Semaglutide Pen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Nov 2025to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kevin Yau, MD contact
Canada2 sites, 2 recruiting
- Recruiting
Unity Health Toronto
Toronto, Ontario, M5B1W8
Ron Wald, MD, (416) 867-3703, ron.wald@unityhealth.to
Kevin Yau, MD, Kevin.Yau@uhn.ca
- Recruiting
Unity Health Toronto
Toronto, Ontario, M5B1W8
Ivana Prce, 416 867 7460 x 48109, ivana.prce@unityhealth.to
About this study
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.
Read the 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.
- Being tested
- Semaglutide Pen
- Keywords
- Dialysis, Type 2 diabetes, semaglutide, end stage kidney disease, GLP1, GLP1RA
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Kidney Failure, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide PenDrug
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 group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | This treatment arm comprises a strategy of usual care for type 2 diabetes mellitus |
| Semaglutide | Experimental | Individuals randomized to this arm will take semaglutide once weekly. Receives: Drug: Semaglutide Pen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (6)
Study Medication Discontinuation
The number of enrolled participants who permanently discontinue the study medication in the semaglutide arm from baseline to 6 months.
Measured: 26 weeks
Feasibility of Study Recruitment
This will be determined if ≥ 40% of the number of fully eligible participants (potential participants who were screened and identified to meet inclusion/exclusion criteria) consent to participate in the trial.
Measured: 26 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
We will measure the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] and identify safety events of special interest such as gastrointestinal symptoms, acute biliary disease, acute pancreatitis, interventions for diabetic retinopathy, heart failure exacerbations, malignant neoplasms, and the number of hypoglycemic events.
Measured: 26 weeks
Major Adverse Cardiovascular Events
This is a composite of CV death, non-fatal myocardial infarction, non-fatal stroke, or a peripheral arterial event.
Measured: 26 weeks
Follow Up Percentage at 26 weeks
To determine if ≥ 90% of participants (who are enrolled) will be successfully followed to week 26 (end of study participation).
Measured: 26 weeks
Patient Reported Measures
The validated EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) score will be used to evaluate baseline-adjusted changes in quality of life and symptom burden. The EQ-5D-5L asks individuals to rate their overall health on a visual scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start27 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Ron Wald, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017270
- Sponsor's protocol ID
- CTO5185
- Acronym
- GUARD-1
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
- ClinicalTrials.gov ID
- NCT07017270
- Acronym / sponsor ID
- GUARD-1 / CTO5185
- Keywords
- Dialysis, Type 2 diabetes, semaglutide, end stage kidney disease, GLP1, GLP1RA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –This treatment arm comprises a strategy of usual care for type 2 diabetes mellitus |
| Semaglutide | Experimental | Drug: Semaglutide PenIndividuals randomized to this arm will take semaglutide once weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide PenIndividuals 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. | Drug | Semaglutide |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin Yau, MD contact
Dr. Ron Wald, MD principal investigator
Unity Health Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide Pen in people with Kidney Disease, Chronic and Diabetes, run by Unity Health Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ron Wald, MD ((416) 867-3703, ron.wald@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence of Study Intervention (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.