Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

Sponsor
Western University, Canada
Study ID
NCT06396416
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 26, 2024
Status verified
Feb 2026
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Virtual Weight Management Program
    A maximum tolerated dose of semaglutide (Ozempic/Wegovy) will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.
  • No Intervention: Usual Care
    Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Primary Outcome Measure

Feasibility of Recruitment [ Time Frame: 12 months ]

Central Contacts

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