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Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

ConditionsObesityChronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older

BMI; 35 kg/m²

10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Virtual Weight Management ProgramExperimental treatment 2 interventions
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Feasibility of Recruitment

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

Time frame
12 months

Secondary outcomes

1

Adherence to Scheduled Coaching Visits

Percentage of participants randomized to the intervention attend \>75% of their scheduled coaching visits.

Time frame
12 months
2

Adherence to GLP-1RA Therapy

Percentage of participants randomized to the intervention fill \>75% of their semaglutide prescriptions.

Time frame
12 months
3

Recruitment of ≥20 Participants in First 12 Weeks

Recruitment of ≥20 participants in first 12 Weeks of trial initiation

Time frame
First 12 weeks
4

Recruitment Per Site Within 12 Weeks

At least one participant recruited per site within 12 weeks of trial initiation each active site

Time frame
First 12 weeks

Other outcomes

1

Percentage of Change in HbA1c

Percentage of change in HbA1c from baseline to 26 weeks, measured in percentage

Time frame
26 weeks
2

Change in 2-week glycemic variability

For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in 2-week glycemic variability from baseline to 26 weeks

Time frame
26 weeks
3

Change in Time-in-Range

For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in Time-in-Range from baseline to 26 weeks

Time frame
26 weeks

Sponsors and contacts

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Western University, Canada

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Queen Elizabeth II Health Sciences Centre

Collaborator

Unity Health Toronto

Collaborator

Source ClinicalTrials.gov
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