Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493526
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-18
Brief Title:
Mycophenolate-Based Therapy for Kidney Transplant Recipients Without HLA-DQ Mismatch
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Safety of Calcineurin-Inhibitor Withdrawal in Zero-HLA DQ-Mismatched Kidney Transplant Recipients on a Concentration Controlled Mycophenolate Dose A Prospective Single Arm Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
MyQURE
Brief Summary:
The goal of this clinical trial is to learn if calcineurin-inhibitor therapy a drug commonly used to prevent rejection can be safely stopped in kidney transplant recipients with a relatively low risk of rejection being recipients of a first transplant without any signs of pre-existing immunity against the graft and having a good HLA match with the donor no mismatch in HLA-DQ Before stopping the calcineurin-inhibitors the remaining therapy with mycophenolate mofetil and corticosteroids will be optimizedThe main questions it aims to answer are
Is this approach safe in terms of preventing rejection Is this approach well tolerated Will this approach lead to better kidney function andor other beneficial effects
Is this approach safe in terms of preventing rejection Is this approach well tolerated Will this approach lead to better kidney function andor other beneficial effects
Detailed Description:
In summary this pilot prospective single-arm open interventional study the investigators will include immune-quiescent zero-DQ mismatched kidney transplant recipients between 3-12 months post-transplant who are on a CNI-based regimen with corticosteroids and MMF After optimization of MMF dose targeted at an MPA AUC12 of 60 15 mghL CNIs will be tapered and stopped over a 4 week peri-od Prednisolon dose will be temporarily increased to 10 mgday at the day of CNI withdrawal for 14 days and continued at 5 mgd thereafter The primary outcome is biopsy-proven rejection at 6 months after CNI withdrawal Secondary outcomes will look at other markers of alloreactivity dnD-SA without clinical or histological signs of rejection tolerability of MMF in the defined range infec-tious complications and possible favorable effects of CNI withdrawal on GFR tubular function blood pressure lipid profile and diabetes
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?:
False
Is an FDA AA801 Violation?:
None