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ObesityPhase 4NCT06396416

Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

A Phase 4 study testing Semaglutide and Virtual Weight Management Coaching in people with Obesity and Chronic Kidney Disease, run by Western University, Canada at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Chronic Kidney Disease
What is being tested?
Semaglutide and Virtual Weight Management Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
26 Sep 2024to Dec 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heather LaPier, BSc contact

519-646-6100 ext. 65373

heather.lapier@sjhc.london.on.ca

Canada1 site, 1 recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

    Heather LaPier, BSc, 519-646-6100 ext. 65373, heather.lapier@sjhc.london.on.ca

    Louise Moist, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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?
Being tested
Semaglutide, Virtual Weight Management Coaching
Keywords
Weight Management, Transplant, GLP-1RA, Pilot Study, Registries, Pragmatic
Medical subject headings
Obesity, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Also called GLP-1RA, Ozempic, Wegovy

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

  • Virtual Weight Management CoachingBehavioural

    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.

Study groups in NCT06396416
Study groupRoleWhat they receive
Virtual Weight Management ProgramExperimentalA 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.
Receives: Drug: Semaglutide; Behavioral: Virtual Weight Management Coaching
Usual CareNo interventionUsual 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (16)

  1. Adherence to Scheduled Coaching Visits

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

    Measured: 12 months

  2. Adherence to GLP-1RA Therapy

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

    Measured: 12 months

  3. Recruitment of ≥20 Participants in First 12 Weeks

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

    Measured: 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

    Measured: First 12 weeks

  5. Incidence of Acute Kidney Injury

    Number of participants experiencing acute kidney injury (AKI)

    Measured: 12 months

  6. Incidence of Hypoglycemia

    Number of participants experiencing hypoglycemia

    Measured: 12 months

  7. Incidence of Gastrointestinal Side Effects

    Number of participants experiencing GI side effects

    Measured: 12 months

  8. 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).

    Measured: 26 weeks

  9. 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.

    Measured: 26 weeks

  10. 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.

    Measured: 26 weeks

  11. Change in Body Fat - Smart Scale

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

    Measured: 26 weeks

  12. Change in Muscle Mass - Smart Scale

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

    Measured: 26 weeks

  13. 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.

    Measured: 26 weeks

  14. In-Clinic Height Measurement

    In-clinic height measurements, measured in centimeters

    Measured: Baseline, 3 months, 6 months

  15. In-Clinic Weight Measurement

    In-clinic weight measurements, measured in kilograms

    Measured: Baseline, 3 months, 6 months

  16. In-Clinic Body Mass Index Measurement

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

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start26 Sep 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06396416
Sponsor's protocol ID
OK-TRANSPLANT 2
Status last verified
Jun 2026
First submitted
29 Apr 2024
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Demographics (age, sex, etc.) Baseline characteristics Lab Values Outcome Measurements Adverse event data Other data points collected for each participant

Publications

  • Clemens KK, Irwin J, Chiu M, Dixon S, Bendo NJ, Varughese P, Vinson AJ, Lapier H, Attalla D, Ernst J, Khan T, Young A, Yau K, Craig L, Reichert S, Sener A, Moist LM. Obesity management for kidney TRANSPLANTation: protocol for the vanguard phase of an innovative randomised controlled trial, embedded in routine care (OK-TRANSPLANT 2). BMJ Open. 2026 Aug 11;16(8):e120427. doi: 10.1136/bmjopen-2026-120427.

    PubMed 42580835

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Semaglutide and Virtual Weight Management Coaching in people with Obesity and Chronic Kidney Disease, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heather LaPier, BSc (519-646-6100 ext. 65373, heather.lapier@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06396416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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