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GUARD-1
Not yet recruitingPhase 4Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
100
estimated
Study population
Chronic kidney disease, Type 2 diabetes
Key I/E criterion
—
Primary endpoint
•Adherence of Study Intervention
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age ≥ 18
2. Receiving chronic maintenance hemodialysis or peritoneal dialysis for ≥ 90 days
3. confirmed DM2 based on medical history and current or prior receipt of an oral hypoglycemic agent and/or insulin.
4. Ability to provided informed consent or through their substitute decision maker
Exclusion criteria
1. Type 1 DM
2. Use of a GLP-1-RA within 30 days prior to screening
3. 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)
4. Confirmed pregnancy, women of childbearing potential
5. Known hypersensitivity to GLP-1-RA
6. Expected to recover kidney function, stop hemodialysis, pursue palliative care, or transplantation within 6 months
7. Enrolment in another clinical trial judged by the investigator to interact with the effect of GLP1-RA
Endpoints (7)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Cardiovascular outcomes
1 endpointMajor Adverse Cardiovascular Events
Time frame:26 weeks
Expanded / custom MACE composite
composite event, event
componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Peripheral-artery outcome composite
Patient-reported / QoL
1 endpointPatient Reported Measures
Time frame:26 weeks
EQ-5D VAS
change from baseline, improvement
Safety / tolerability / PK
2 endpointsStudy Medication Discontinuation
Time frame:26 weeks
Discontinuation due to AE
event count, event
Safety Events of Special Interest
Time frame:26 weeks
descriptive
componentsNausea, Vomiting, Diarrhea, Gallbladder event, Pancreatitis, Documented hypoglycemia
Other (unclassified)
3 endpointsAdherence of Study Intervention
Time frame:26 weeks
threshold achievement, descriptive
Feasibility of Study Recruitment
Time frame:26 weeks
threshold achievement, descriptive
Follow Up Percentage at 26 weeks
Time frame:26 weeks
threshold achievement, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.