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NCT Number: NCT06396416

Obesity Management for Kidney TRANSPLANTation: 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location status: Recruiting

Location contact

Heather LaPier, BSc

CONTACT

[email protected]

519-646-6100 ext. 65373

Louise Moist, MD

PRINCIPAL_INVESTIGATOR

Michael Chiu, MD

SUB_INVESTIGATOR

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (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
  • Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one

Treatment and study plan

semaglutide

Drug

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

Other names: GLP-1RA, Ozempic, Wegovy

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.

Primary outcomes

  1. Feasibility of Recruitment

    Time frame: 12 months

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

Secondary outcomes

  1. Adherence to Scheduled Coaching Visits

    Time frame: 12 months

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

  2. Adherence to GLP-1RA Therapy

    Time frame: 12 months

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

  3. Recruitment of ≥20 Participants in First 12 Weeks

    Time frame: First 12 weeks

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

  4. Recruitment Per Site Within 12 Weeks

    Time frame: First 12 weeks

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

  5. Incidence of Acute Kidney Injury

    Time frame: 12 months

    Number of participants experiencing acute kidney injury (AKI)

  6. Incidence of Hypoglycemia

    Time frame: 12 months

    Number of participants experiencing hypoglycemia

  7. Incidence of Gastrointestinal Side Effects

    Time frame: 12 months

    Number of participants experiencing GI side effects

  8. Change in Dalhousie Clinical Frailty Scale Classification

    Time frame: 26 weeks

    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).

  9. Change in SARC-F Score of Sarcopenia

    Time frame: 26 weeks

    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.

  10. Change in Body Weight - Smart Scale

    Time frame: 26 weeks

    Change in weight from baseline to 26 weeks, measured in kilograms. Measured using a Smart Scale in a subpopulation.

  11. Change in Body Fat - Smart Scale

    Time frame: 26 weeks

    Change in body fat from baseline to 26 weeks, measured in percentage. Measured using Smart Scale in subpopulation.

  12. Change in Muscle Mass - Smart Scale

    Time frame: 26 weeks

    Change in muscle mass from baseline to 26 weeks. Measured in kilograms. Measured using Smart Scale in subpopulation.

  13. Change in Body Water Content - Smart Scale

    Time frame: 26 weeks

    Change in body water content from baseline to 26 weeks. Measured in percentage. Measured using Smart Scale in subpopulation.

  14. In-Clinic Height Measurement

    Time frame: Baseline, 3 months, 6 months

    In-clinic height measurements, measured in centimeters

  15. In-Clinic Weight Measurement

    Time frame: Baseline, 3 months, 6 months

    In-clinic weight measurements, measured in kilograms

  16. In-Clinic Body Mass Index Measurement

    Time frame: Baseline, 3 months, 6 months

    In-clinic BMI measurements, measured in kg/m^2

Other outcomes

  1. Percentage of Change in HbA1c

    Time frame: 26 weeks

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

  2. Change in 2-week glycemic variability

    Time frame: 26 weeks

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

  3. Change in Time-in-Range

    Time frame: 26 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Heather LaPier, BSc

CONTACT

[email protected]

519-646-6100 ext. 65373

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
  • Queen Elizabeth II Health Sciences Centre
  • Unity Health Toronto

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 2, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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