Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-26

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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?

Conditions

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Obesity Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Double: Double (Investigator, Outcomes Assessor)

Study Groups

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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.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

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

Virtual Weight Management Coaching

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Semaglutide

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

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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GLP-1RA Ozempic Wegovy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No