Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01780844
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2013-01-29
Brief Title:
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2a Randomized Open-label Active Control Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2023-12
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:
The purpose of this study is to evaluate the efficacy and safety of ASKP1240 an anti-CD40 monoclonal antibody for the prophylaxis of organ rejection after kidney transplantation This study will compare the efficacy of basiliximab induction ASKP1240 mycophenolate mofetil MMF and steroids calcineurin inhibitor CNI avoidance to the standard of care immunosuppressive regimen basiliximab induction tacrolimus MMF steroids In addition the study will compare the efficacy of basiliximab induction ASKP1240 tacrolimus and steroids CNI minimization-MMF avoidance to the standard of care immunosuppressive regimen basiliximab induction tacrolimus MMF steroids
Detailed Description:
Subjects will be followed for 6 months Upon completion of the first 6 months of the study subjects may participate in the Long Term Extension period of the study Subjects will remain on their original treatment arm up to three years post-transplant and or Sponsor discontinues development or the subject no longer wishes to participate in the study
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?:
None
Is an FDA AA801 Violation?:
None