Health TrialsbyHealthPanel

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

ConditionsKidney Disease, ChronicDiabetesDialysisEnd Stage Kidney Disease (ESRD)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide Pen

    Drug

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Usual Care GroupNo intervention 0 interventions
Group B: SemaglutideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
26 weeks

Secondary outcomes

1

Study Medication Discontinuation

The number of enrolled participants who permanently discontinue the study medication in the semaglutide arm from baseline to 6 months.

Time frame
26 weeks
2

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.

Time frame
26 weeks
3

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.

Time frame
26 weeks
4

Major Adverse Cardiovascular Events

This is a composite of CV death, non-fatal myocardial infarction, non-fatal stroke, or a peripheral arterial event.

Time frame
26 weeks

Other outcomes

Sponsors and contacts

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Unity Health Toronto

Lead sponsor

Source ClinicalTrials.gov
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