Clinical trial NCT06396416: Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2
Official title: Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity
Chronic Kidney Disease
Keywords: Weight Management
Transplant
GLP-1RA
Pilot Study
Registries
Pragmatic
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Queen Elizabeth II Health Sciences Centre
name: St. Michael&#39;s Hospital (Toronto, Canada)
First posted: 2024-05-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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?

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older
* BMI \&gt; 35 kg/m\^2
* \&gt;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
* Current use of more than the starting dose of semaglutide, liraglutide, or dulaglutide
* No access to semaglutide via drug coverage
* Absolute contraindication to kidney transplant
* Pregnant, breastfeeding or planning to become pregnant

Primary outcomes:
measure: Recruitment Rate
timeFrame: 12 months
Secondary outcomes:
measure: Adherence to Scheduled Coaching Visits
timeFrame: 26 weeks
measure: Adherence to Study Medication
timeFrame: 26 weeks
measure: Crossover of Intervention and Control
timeFrame: 26 weeks
measure: Adverse events
timeFrame: 26 weeks
Other outcomes:
measure: Percentage of Change in HbA1c
timeFrame: 26 weeks
measure: Change in 2-week mean fasting glucose
timeFrame: 26 weeks
measure: Change in 2-week glycemic variability and time in range (TIR)
timeFrame: 26 weeks
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Kristin K Clemens, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre
name: Louise Moist, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: