Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503731
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients with Antibody-Mediated Rejection AMR
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Global Multicenter Randomized Double-Blinded Placebo-Controlled Phase 2 Study to Evaluate the Safety Tolerability and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients with Antibody-Mediated Rejection
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Shamrock
Brief Summary:
The purpose of this study is to assess the safety tolerability and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection AMR after kidney transplantation
After a screening period of up to 6 weeks eligible participants will be randomized in a 111 ratio The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy tacrolimus mycophenolate mofetil steroids during the treatment period 48 weeks At the end of the treatment period the participants will enter an observationalfollow-up period approximately 24 weeks The participants will be in the study for up to 78 weeks
After a screening period of up to 6 weeks eligible participants will be randomized in a 111 ratio The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy tacrolimus mycophenolate mofetil steroids during the treatment period 48 weeks At the end of the treatment period the participants will enter an observationalfollow-up period approximately 24 weeks The participants will be in the study for up to 78 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None