Clinical trial

Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06396416

Recruiting nowPhase 4Interventional

What this study is about

OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial. We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.

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

ConditionObesity, Chronic Kidney Disease

Full registry criteria

Inclusion Criteria: * Adults aged 18 years or older * BMI; 35 kg/m\^2 * 10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis Exclusion Criteria: * Known contraindication to a GLP-1RA (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity) * Type 1 diabetes * No access to semaglutide via drug coverage * Pregnant, breastfeeding or planning to become pregnant * Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one

Treatments and study arms

Semaglutide

Drug

Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.

Virtual Weight Management Coaching

Behavioral

Virtual meeting with intervention coach once every 4 weeks for 6 months, where the coach will discuss the goals and progress with participant, nutritional advice, exercise advice, and motivational support.

Primary outcomes

Feasibility of Recruitment12 months

Number of participants enrolled across three centers, with success defined as recruitment of ≥ 60 participants within the 12-month enrollment period.

Study locations

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

London Health Sciences Centre🇨🇦 London, Ontario, Canada

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Heather LaPier, BScContact

Email · Call 519-646-6100

Louise Moist, MDPrincipal Investigator

Michael Chiu, MDSub Investigator