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

NCT ID: NCT07017270

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-09-30

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

Conditions

Kidney Disease, Chronic; Diabetes; Dialysis; End Stage Kidney Disease (ESRD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care Group

This treatment arm comprises a strategy of usual care for type 2 diabetes mellitus

Group Type: NO_INTERVENTION

No interventions assigned to this group

Semaglutide

Individuals randomized to this arm will take semaglutide once weekly.

Group Type: EXPERIMENTAL

Semaglutide Pen

Intervention Type: 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.

Interventions

Semaglutide Pen

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unity Health Toronto

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Ron Wald, MD

Role: CONTACT

ron.wald@unityhealth.to

(416) 867-3703

Kevin Yau, MD

Role: CONTACT

Kevin.Yau@uhn.ca

Facility Contacts

Ron Wald, MD

Role: primary

ron.wald@unityhealth.to

(416) 867-3703

Kevin Yau, MD

Role: backup

Kevin.Yau@uhn.ca

Other Identifiers

CTO5185

Identifier Type: -

Identifier Source: org_study_id