Weight management program for kidney transplant candidates with obesity
Obesity Management for Kidney TRANSPLANTation: a Vanguard Study for an Innovative Randomized Controlled Trial, Embedded in Routine Care (OK-TRANSPLANT 2)
This study is testing whether a virtual weight management program can help adults with obesity and kidney disease who are waiting for a transplant lose weight more effectively than their usual care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06396416 on ClinicalTrials.gov |
What this trial studies
OK-TRANSPLANT 2 is a pilot study designed to evaluate the feasibility of a virtual weight management program for adults with obesity and high-risk chronic kidney disease (CKD) who are seeking kidney transplantation. Participants will be randomized to either receive coaching on weight management using GLP-1 receptor agonists or continue with their usual care. The study aims to address the challenges of weight loss in this population, which is often complicated by dietary restrictions and functional impairments. By assessing recruitment and trial processes, this study will lay the groundwork for a larger randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a BMI greater than 35 kg/m² and a significant risk of end-stage kidney disease.
Not a fit: Patients who have type 1 diabetes or known contraindications to GLP-1 receptor agonists will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve access to kidney transplantation for patients with obesity and CKD by providing effective weight management strategies.
How similar studies have performed: While weight management in CKD patients has been explored, the specific use of GLP-1 receptor agonists in this context is novel and has not been extensively tested in dedicated trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Currently in a GLP-1RA or GLP-1RA/GIP study or planning to be in one
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kristin K Clemens, MD, MSc — St. Joseph's Health Care London
- Study coordinator: Heather LaPier, BSc
- Email: heather.lapier@sjhc.london.on.ca
- Phone: 519-646-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.