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)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Chronic Kidney Disease
• Intervention / Treatment: Drug: Semaglutide; Behavioral: Virtual Weight Management Coaching

Detailed Description

Obesity is well-recognized as an independent risk factor for chronic kidney disease (CKD) including end-staged kidney disease (ESKD). In people with ESKD, obesity can preclude access to lifesaving kidney transplantation. Of solid organ transplant programs in Canada, 80% exclude people with obesity (based upon body mass index or BMI), due to a potential risk of perioperative complications and post-transplant mortality.

Losing weight for kidney transplantation can, however, be extremely difficult. Medications that can promote weight loss in other populations including glucagon-like peptide 1 receptor agonists (GLP-1RA; liraglutide, semaglutide, and dulaglutide) and glucose-dependent insulinotropic polypeptide (GIP-1RA)/GLP-1RAs (tirzepatide), have not been studied in devoted trials of advanced CKD participants, and their efficacy and safety remain unclear.

Nutritional advice is often very difficult to follow when trying to balance kidney and diabetes diets (e.g. potassium), and if diets are too restrictive, there may be protein-energy wasting which could be detrimental to patients. People with high-risk CKD frequently live with functional impairment which can limit exercise. Weight loss programs can be cost prohibitive to those who are already socioeconomically disadvantaged.

A vanguard is needed before a large, multicentered RCT: A feasibility study will allow us to ensure that we can recruit a sufficient sample of participants into our trial, that our trial processes are inclusive, and that they are acceptable to patients. In the vanguard phase of our trial, we will answer the following questions:

1. Is participant recruitment into a large multi-centered trial feasible?
2. Will participants remain adherent to their assigned treatment arm over 26 weeks of study?
3. Will participants find our program acceptable?
4. Will safety events preclude us from testing our intervention in a larger RCT?

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Heather LaPier, BSc; Phone Number: 65373 519-646-6100; Email: heather.lapier@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Recruiting
      • London Health Sciences Centre
      • Contact: Heather LaPier, BSc; Phone Number: 65373 519-646-6100; Email: heather.lapier@sjhc.london.on.ca
      • Principal Investigator: Louise Moist, MD
      • Sub-Investigator: Michael Chiu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Semaglutide; Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.; Other Names: Ozempic; Wegovy; GLP-1RA; Behavioral: Virtual 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Scheduled Coaching Visits	Percentage of participants randomized to the intervention attend >75% of their scheduled coaching visits.	12 months
Adherence to GLP-1RA Therapy	Percentage of participants randomized to the intervention fill >75% of their semaglutide prescriptions.	12 months
Recruitment of ≥20 Participants in First 12 Weeks	Recruitment of ≥20 participants in first 12 Weeks of trial initiation	First 12 weeks
Recruitment Per Site Within 12 Weeks	At least one participant recruited per site within 12 weeks of trial initiation each active site	First 12 weeks
Incidence of Acute Kidney Injury	Number of participants experiencing acute kidney injury (AKI)	12 months
Incidence of Hypoglycemia	Number of participants experiencing hypoglycemia	12 months
Incidence of Gastrointestinal Side Effects	Number of participants experiencing GI side effects	12 months
Change in Dalhousie Clinical Frailty Scale Classification	Change in participant's Dalhousie Clinical Frailty Scale Classification from baseline to 26 weeks. The scale has 9 options, from 1 (very fit) to 9 (terminally ill).	26 weeks
Change in SARC-F Score of Sarcopenia	Change in participant's SARC-F questionnaire score from baseline to 26 weeks. Out of 8 points, a SARC-F score of ≥4 best predicts the need for further, more comprehensive clinical evaluation.	26 weeks
Change in Body Weight - Smart Scale	Change in weight from baseline to 26 weeks, measured in kilograms. Measured using a Smart Scale in a subpopulation.	26 weeks
Change in Body Fat - Smart Scale	Change in body fat from baseline to 26 weeks, measured in percentage. Measured using Smart Scale in subpopulation.	26 weeks
Change in Muscle Mass - Smart Scale	Change in muscle mass from baseline to 26 weeks. Measured in kilograms. Measured using Smart Scale in subpopulation.	26 weeks
Change in Body Water Content - Smart Scale	Change in body water content from baseline to 26 weeks. Measured in percentage. Measured using Smart Scale in subpopulation.	26 weeks
In-Clinic Height Measurement	In-clinic height measurements, measured in centimeters	Baseline, 3 months, 6 months
In-Clinic Weight Measurement	In-clinic weight measurements, measured in kilograms	Baseline, 3 months, 6 months
In-Clinic Body Mass Index Measurement	In-clinic BMI measurements, measured in kg/m^2	Baseline, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Change in HbA1c	Percentage of change in HbA1c from baseline to 26 weeks, measured in percentage	26 weeks
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	26 weeks
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	26 weeks

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Unity Health Toronto; Queen Elizabeth II Health Sciences Centre; London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Investigators: Principal Investigator: Kristin K Clemens, MD, MSc, St. Joseph's Health Care London; Principal Investigator: Louise Moist, MD, MSc, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Transplant; Registries; Weight Management; Pilot Study; Pragmatic; GLP-1RA
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Overnutrition; Body Weight; Renal Insufficiency; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Renal Insufficiency, Chronic; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: OK-TRANSPLANT 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No