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← All trials/NCT07017270

GUARD-1

Not yet recruitingPhase 4

Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

100

Study population

Chronic kidney disease, Type 2 diabetes

Eligibility highlights

-

Primary endpoint

•Adherence of Study Intervention

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07017270
Org study IDCTO5185

Timeline

Milestones

Study first posted2025-06-12actual
Last update posted2025-06-12actual
Study start2025-07estimated (month precision)
Primary completion2027-07estimated (month precision)
Study completion2027-09estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
3
Safety / tolerability / PK
2
Cardiovascular outcomes
1
Patient-reported / QoL
1

Cardiovascular outcomes

1 endpoint
Secondary/protocol endpoint

Major 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 endpoint
Secondary/protocol endpoint

Patient Reported Measures

Time frame:26 weeks

EQ-5D VAS

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Study Medication Discontinuation

Time frame:26 weeks

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Safety Events of Special Interest

Time frame:26 weeks

descriptive

componentsNausea, Vomiting, Diarrhea, Gallbladder event, Pancreatitis, Documented hypoglycemia

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Adherence of Study Intervention

Time frame:26 weeks

threshold achievement, descriptive

Secondary/protocol endpoint

Feasibility of Study Recruitment

Time frame:26 weeks

threshold achievement, descriptive

Secondary/protocol endpoint

Follow Up Percentage at 26 weeks

Time frame:26 weeks

threshold achievement, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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 6, 2026 snapshot.