Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474273
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients
Status:
NOT_YET_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:
None
Brief Summary:
After a kidney or a simultaneous kidney-pancreas transplant some patients may face problems with their new organs This happens because the body sometimes makes a mistake and tries to get rid of the organ This problem is called rejection One type of rejection is known as Acute T cell mediated rejection TCMR This can lead to many problems or even stop the transplant from working
Doctors give strong steroids to treat this problem but there are no rules for how much steroid to give Too much steroids can cause problems like heart and bone problems bad infections and weight gain Thats why we need to find the right dose of steroids for each person to treat this
TACKLE-IT is a study that will try to find the right steroid dose for treating rejection
Doctors give strong steroids to treat this problem but there are no rules for how much steroid to give Too much steroids can cause problems like heart and bone problems bad infections and weight gain Thats why we need to find the right dose of steroids for each person to treat this
TACKLE-IT is a study that will try to find the right steroid dose for treating rejection
Detailed Description:
TACKLE-IT is an international multi-centre 2x2 factorial registry-based single-blind randomised controlled trial RCT that compares the effectiveness and safety of high vs low dose IV MP and high vs low dose oral prednisone taper as the first-line therapy for acute TCMR in kidney and SPK transplant recipients This RCT was conceived and developed through extensive consultation and collaboration with our key stakeholders including transplant recipients with lived experience and the International TCMR Working Group with sponsorship by 4 international transplant societies The Transplantation Society TTS American Society of Transplantation AST European Society of Transplantation ESOT and Transplant Society of Australia and New Zealand TSANZ TACKLE-IT is led by an international multi-disciplinary team of transplant health professionals clinical trialists biostatisticians health economist social scientist consumers
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