Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

NCT06396416 | Recruiting Phase 4 DMC

• 1 other identifier: OK-TRANSPLANT 2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Chronic Kidney Disease

Keywords

Weight Management; Transplant; GLP-1RA; Pilot Study; Registries; Pragmatic

Outcome Measures

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.

  12 months

Secondary Outcomes (16)

• Adherence to Scheduled Coaching Visits

  12 months

• Adherence to GLP-1RA Therapy

  12 months

• Recruitment of ≥20 Participants in First 12 Weeks

  First 12 weeks

• Recruitment Per Site Within 12 Weeks

  First 12 weeks

• Incidence of Acute Kidney Injury

  12 months

Other Outcomes (3)

• Percentage of Change in HbA1c

  26 weeks

• Change in 2-week glycemic variability

  26 weeks

• Change in Time-in-Range

  26 weeks

Study Arms (2)

Virtual Weight Management Program

EXPERIMENTAL

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.

Drug: Semaglutide; Behavioral: Virtual Weight Management Coaching

Usual Care

NO INTERVENTION

Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Interventions

Semaglutide DRUG

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

Also known as: GLP-1RA, Ozempic, Wegovy

Virtual Weight Management Program

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.

Virtual Weight Management Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Elizabeth II Health Sciences Centre: collaborator
• Western University, Canada: lead
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• Unity Health Toronto: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Renal Insufficiency, Chronic

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Kristin K Clemens, MD, MSc

  St. Joseph's Health Care London

  PRINCIPAL INVESTIGATOR

• Louise Moist, MD, MSc

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather LaPier, BSc

CONTACT

519-646-6100; heather.lapier@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double: Double (Investigator, Outcomes Assessor)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: September 26, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)