Clinical trial NCT07017270: Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
Official title: Glucagon-like-peptide-1 Receptor Agonists in Patients Receiving Maintenance Dialysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Kidney Disease, Chronic
Diabetes
Dialysis
End Stage Kidney Disease (ESRD)
Keywords: Dialysis
Type 2 diabetes
semaglutide
end stage kidney disease
GLP1
GLP1RA
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: In this randomized pilot study, Individuals randomized to the active intervention arm will take semaglutide once weekly. Semaglutide (injectable, 1.34 mg/mL) is delivered subcutaneously via a multiple-use pen-injector that can be used to dial in all required doses on the same pen-injector. The clinical pen has a drum scale of 1-80 in increments of 1. Participants will be trained/re-trained on injector use at 0, 4, 8, and 12 weeks. For participants receiving in-centre hemodialysis, the intervention may be administered during the dialysis session by nursing personnel. Semaglutide will be titrated using an algorithm used in previous trials with a starting dose of 0.25 mg/week, with an increase to 0.5 mg/week after 4 weeks, and to the maximum dose of 1.0 mg/week after 8 weeks as tolerated. If a participant experiences an adverse effect, efforts will be made to maintain the current dosage, with dose reductions or treatment pauses permitted at the discretion of the site investigator. Patient receiving concomitant insulin therapy will have therapy adjusted as per a pre-specified algorithm. Participants allocated to the usual care arm will receive usual care.

Primary outcomes:

1. Feasibility of study recruitment: ≥ 40% of fully eligible patients consent to participate in the trial.
2. Adherence to intervention: ≥ 70% of enrolled patients are adherent to the study intervention over the 26-week follow-up period.
3. Ability to follow: ≥ 90% of participants will be successfully followed to week

Secondary outcomes:

* Proportion Discontinuing Intervention
* Safety Events
* Major Adverse Cardiovascular Outcomes (Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or a peripheral arterial event)
* Body Weight/BMI
* Systolic/diastolic blood pressure
* Insulin dosage, glycemic control (HbA1c and random glucose)
* Lipid profile
* Hemoglobin, Calcium, Phosphate, PTH
* EQ-5D-5L for baseline-adjusted changes in quality of life and symptom burden

Eligibility criteria: 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

Primary outcomes:
measure: Adherence of Study Intervention
timeFrame: 26 weeks
Secondary outcomes:
measure: Study Medication Discontinuation
timeFrame: 26 weeks
measure: Feasibility of Study Recruitment
timeFrame: 26 weeks
measure: Safety Events of Special Interest
timeFrame: 26 weeks
measure: Major Adverse Cardiovascular Events
timeFrame: 26 weeks
measure: Follow Up Percentage at 26 weeks
timeFrame: 26 weeks
measure: Patient Reported Measures
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
Study officials:
References: