NCT06396416 Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2
| NCT ID | NCT06396416 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Western University, Canada |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-26 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2024-09-26 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Kristin K Clemens, MD, MSc
PRINCIPAL INVESTIGATOR
St. Joseph's Health Care London
Frequently Asked Questions
Who can join the NCT06396416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06396416 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06396416 currently recruiting?
Yes, NCT06396416 is actively recruiting participants. Contact the research team at heather.lapier@sjhc.london.on.ca for enrollment information.
Where is the NCT06396416 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06396416 clinical trial?
NCT06396416 is sponsored by Western University, Canada. The principal investigator is Kristin K Clemens, MD, MSc at St. Joseph's Health Care London. The trial plans to enroll 60 participants.
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