Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396416
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-29
Brief Title:
Obesity Management for Kidney TRANSPLANTation OK-TRANSPLANT 2
Sponsor:
Western University Canada
Organization:
Western University Canada
Study Overview
Official Title:
Obesity Management for Kidney TRANSPLANTation a Vanguard Study for an Innovative Randomized Controlled Trial Embedded in Routine Care OK-TRANSPLANT 2
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CKDdialysis 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
We will randomize participants with obesity high-risk CKDdialysis 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-1RAGLP-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 eg 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
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-1RAGLP-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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None