RecruitingPhase 4NCT06396416

Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)


Sponsor

Western University, Canada

Enrollment

60 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a structured obesity management program — combining diet, lifestyle coaching, and possibly medication — to help kidney transplant candidates lose enough weight to become eligible for transplantation. **You may be eligible if...** - You have end-stage kidney disease and are being evaluated for a kidney transplant - You have a BMI (body mass index) that currently makes you ineligible or borderline for transplant listing - You are motivated and able to participate in a structured weight management program - You are at least 18 years old **You may NOT be eligible if...** - You have a contraindication to the weight management interventions being used (e.g., certain medications) - You have uncontrolled heart disease or other unstable medical conditions - You are pregnant or planning pregnancy during the study - You have already had a prior kidney transplant that failed due to non-immunological reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide

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

BEHAVIORALVirtual Weight Management Coaching

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.


Locations(1)

London Health Sciences Centre

London, Ontario, Canada

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NCT06396416


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