Viewing Study NCT06091995


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Ignite Modification Date: 2025-12-27 @ 10:03 PM
Study NCT ID: NCT06091995
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-11-20
First Post: 2023-07-06
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function
Sponsor: Methodist Health System
Organization:

Study Overview

Official Title: Use of Belatacept to Delay Tacrolimus Initiation in Kidney Transplant Patients with Delayed Graft Function
Status: ACTIVE_NOT_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: Evaluate the impact of one dose of belatacept in patients with Delayed Graft Function(DGF) on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus(BKV), Epstein-Barr Virus(EBV) and/or cytomegalovirus (CMV) infections.
Detailed Description: Evaluate the impact of one dose of belatacept in patients with DGF on their time to renal recovery and corresponding rates of patient and graft survival, rejection, and incidence of BK virus, EBV and/or cytomegalovirus (CMV) infections.

At Methodist Dallas Medical Center(MDMC), while providers may choose to initiate belatacept to delay tacrolimus initiation, the impact of this practice on time to renal recovery has not been evaluated. The purpose of this study is to determine if administering belatacept to delay initiation of tacrolimus shortens time to renal recovery in DGF patients

Study Oversight

Has Oversight DMC: False
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?: