Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538961
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Immune Registry for BK in Kidney Transplant Recipients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Immune Registry for BK Polyomavirus Hominis 1 in Kidney Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Kidney transplantation KT is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients BK nephropathy can affect 8-15 of patients after KT causing acute kidney injury increased risk of rejection and fibrosis leading to additional hospital stays increasing overall health care cost burden and in some cases graft loss The exact pathogenesis and treatment options for BK nephropathy are not clearly understood It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipients latent infection Irrespective of etiology the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection
Detailed Description:
As with other viral infections adaptive immunity plays an essential role in the control of BK virus infection Previous studies have shown that humoral immunity doesnt prevent viral reactivation and cellular responses including CD4 and CD8 T cells play a crucial role in containing viral replication Researchers have investigated the role of reconstitution of BK-specific T cell immunity KT recipients with overall low immunological risk populations showing that pre and post-transplant BK virus-specific cellular responses can be used as an important tool to identify KT recipients at increased risk of developing BK virus infection in the first year post-transplant We plan to understand the role of adaptive immunity cellular and humoral interplay in a cohort with at least 50 of high immunological KT recipients with predominantly retransplant candidates highly sensitized recipients with calculated panel reactive antibodies 40 positive crossmatch or history of prior desensitization therapies
The aim includes the sequential demonstration of immunogenesis processes that are specific to the BK virus in individuals who experience BK viremia and undergo various treatment approaches such as immunosuppression reduction and immune enhancement through intravenous immunoglobulins IVIG
The aim includes the sequential demonstration of immunogenesis processes that are specific to the BK virus in individuals who experience BK viremia and undergo various treatment approaches such as immunosuppression reduction and immune enhancement through intravenous immunoglobulins IVIG
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