Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07017270

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

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

Full registry 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

Treatments and study arms

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.

Primary outcomes

Adherence of Study Intervention26 weeks

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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Unity Health Toronto🇨🇦 Toronto, Ontario, Canada

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Ron Wald, MDContact

Email · Call (416) 867-3703

Kevin Yau, MDContact

Unity Health Toronto🇨🇦 Toronto, Ontario, Canada

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Ivana PrceContact

Email · Call 416 867 7460 x 48109