Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04404127
Status:
RECRUITING
Last Update Posted:
2021-02-18
First Post:
2020-05-19
Brief Title:
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
Sponsor:
King Faisal Specialist Hospital Research Center
Organization:
King Faisal Specialist Hospital Research Center
Study Overview
Official Title:
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2021-02
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:
Background
Induction therapy with IL-2 receptor antagonist IL2-RA is recommended as a first line agent in low immunological risk kidney transplant recipients However the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated
Aims
To compare different induction therapeutic strategies with 2 doses of Basiliximab vs no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol Appendix 2
Methods
Prospective randomized double blind non-inferiority controlled clinical trial
Expected Outcomes
1 Primary outcomes
Biopsy proven acute rejection within first year following transplant
2 Secondary outcomes
1 Patient and graft survival at 1 year
2 Estimated glomerular filtration rate eGFR at 6 months and at 12 months
3 Emergence of de novo donor specific antibodies DSAs
Induction therapy with IL-2 receptor antagonist IL2-RA is recommended as a first line agent in low immunological risk kidney transplant recipients However the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated
Aims
To compare different induction therapeutic strategies with 2 doses of Basiliximab vs no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol Appendix 2
Methods
Prospective randomized double blind non-inferiority controlled clinical trial
Expected Outcomes
1 Primary outcomes
Biopsy proven acute rejection within first year following transplant
2 Secondary outcomes
1 Patient and graft survival at 1 year
2 Estimated glomerular filtration rate eGFR at 6 months and at 12 months
3 Emergence of de novo donor specific antibodies DSAs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None