Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

What Was Tested

This registered phase 4 trial tested Semaglutide.

OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial.

The researchers 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.

It had two arms (groups): Virtual Weight Management Program (experimental) and Usual Care (no intervention).

Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

The registry classes the interventions as behavioral and drug.

More on the Plan

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.

Losing weight for kidney transplantation can, however, be extremely difficult.

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.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults aged 18 years or older. BMI; 35 kg/m\^2.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: known contraindication to a glp-1ra (pancreatitis, personal or family history of medullary thyroid cancer, hypersensitivity); type 1 diabetes; no access to semaglutide via drug coverage.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Semaglutide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2024-09-26 with completion listed for 2026-09-30.

It ran at 1 site in Canada.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Feasibility of Recruitment (time frame: 12 months).

It also tracked 16 secondary outcomes, for example Adherence to Scheduled Coaching Visits, Adherence to GLP-1RA Therapy, Recruitment of ≥20 Participants in First 12 Weeks, Recruitment Per Site Within 12 Weeks, Incidence of Acute Kidney Injury and Incidence of Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.