Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396416
• Other study ID #: 4722
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Western University, Canada
• Contact: Heather LaPier, BSc
• Phone: 519-646-6100
• Email: heather.lapier[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Subjects will either be enrolled on a virtual weight management program or continue their usual care.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic

Intervention

Drug:
• Semaglutide
Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.

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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Western University, Canada	Lawson Health Research Institute, Queen Elizabeth II Health Sciences Centre, Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Change in HbA1c	Percentage of change in HbA1c from baseline to 26 weeks	26 weeks
Other	Change in 2-week mean fasting glucose	Change in 2-week mean fasting glucose (mmol/L) from baseline to 26 weeks	26 weeks
Other	Change in 2-week glycemic variability and time in range (TIR)	For those using a Libre or Continuous Glucose Monitoring at baseline, Percentage of change in 2-week glycemic variability and time in range from baseline to 26 weeks	26 weeks
Primary	Recruitment Rate	Number participants recruited within 12 months of trial initiation at each centre	12 months
Secondary	Adherence to Scheduled Coaching Visits	Percentage of participants randomized to the intervention attend >75% of their scheduled coaching visits.	26 weeks
Secondary	Adherence to Study Medication	Percentage of participants randomized to the intervention fill >75% of their semaglutide prescriptions.	26 weeks
Secondary	Crossover of Intervention and Control	Percentage of participants randomized to the usual care group who are started on a GLP-1RA medication or other weight loss intervention during the study	26 weeks
Secondary	Adverse events	Percentage of participants that experience acute kidney injury (AKI), hypoglycemia, gastrointestinal side effects.	26 weeks