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

Inclusion Criteria3

  • 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 Criteria6

  • Known contraindication to a GLP-1RA
  • Type 1 diabetes
  • No access to semaglutide via drug coverage
  • Absolute contraindication to kidney transplant
  • Pregnant, breastfeeding or planning to become pregnant
  • Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one

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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