Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04404127
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2020-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
Sponsor:
King Faisal Specialist Hospital & Research Center
Organization:
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:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
False
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?: