Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568549
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf Monitoring RIOT Trial A Prospective Randomized Multicenter Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf Monitoring RIOT Trial A Prospective Randomized Multicenter Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIOT
Brief Summary:
The purpose of this research is to determine the safety and efficacy of withdrawing MMF Mycophenolate Mofetil in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant We are comparing them to patients who receive the standard of care Mycophenolate Mofetil
Detailed Description:
Participation will be two years and it involves blood collection collection of medical information and images from standard of care kidney biopsies Subjects will be asked to complete questionnaires for the study at 12 and 24 months after kidney transplant The research blood tests that are being collected for the study are called Trugraf and Viracor Trac The principal investigator is using this test to see if they can predict and monitor rejection in our kidney transplant patients
At the time of the 4 month standard of care kidney biopsy if participants have not experienced any rejection episodes or formed any donor specific antibodies dnDSA and are still eligible randomization will occur Participants will be put into 1 of 2 groups Mycophenolate Mofetil Maintenance group where the subject would continue on current medication or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication If the subject is not eligible to be randomized they will remain in the study and placed into the Non-Randomized group and continue to have study related visits and procedures like the MMF Maintenance group
At the time of the 4 month standard of care kidney biopsy if participants have not experienced any rejection episodes or formed any donor specific antibodies dnDSA and are still eligible randomization will occur Participants will be put into 1 of 2 groups Mycophenolate Mofetil Maintenance group where the subject would continue on current medication or the subject will be placed into the MMF Withdrawal group which means they would slowly be withdrawn from this medication If the subject is not eligible to be randomized they will remain in the study and placed into the Non-Randomized group and continue to have study related visits and procedures like the MMF Maintenance group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None