Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04711850
Status:
TERMINATED
Last Update Posted:
2023-04-06
First Post:
2021-01-13
Brief Title:
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR
Sponsor:
Hansa Biopharma AB
Organization:
Hansa Biopharma AB
Study Overview
Official Title:
A Prospective Observational Long-term Follow-up Trial of Kidney Transplant Patients Treated With Imlifidase or Plasma Exchange After an ActiveChronic Active Antibody-Mediated Rejection Episode
Status:
TERMINATED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This is an internal decision based on prioritisations and no safety issues have been raised during the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection AMR in kidney transplant recipients This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12 in which patients received either imlifidase or plasma exchange PE as AMR treatment Data for parameters such as kidney graft survival patient survival kidney function treatment of rebound of donor specific antibodies DSA and anti-drug antibodies ADAs are collected
Detailed Description:
AMR is one of the most challenging adverse events following kidney transplantation and a major cause of graft dysfunction and graft loss AMR is triggered by donor-specific antibodies DSATransplant glomerulopathy is a known consequence of persistent DSA positivity which results in graft failure and return to dialysis with attendant consequences for the patient and financial costs for the health care system
The time from transplantation to onset of clinical symptoms of AMR varies largely between individuals An early AMR 30 days post-transplant is commonly classified as active AMR and most often triggered by an immunological recall response with pre-existing DSA A late AMR 30 days post-transplant is classified as either active or chronic active AMR and is caused by either a recall DSA response or newly developing naïve immune response associated with de novo DSA production
There is no currently approved therapy for AMR and patients are often treated with a combination of therapies ie high dose IVIg - rituximab PE with low dose IVIg - rituximab and eculizumab which makes analysis of efficacy of any single agent difficult Hence there is a large unmet clinical need for new therapies to treat AMR
Imlifidase is an IgG-degrading enzyme of Streptococcus pyogenes that cleaves all four human subclasses of IgG with high efficacy and specificity The rapidity of the IgG cleavage by imlifidase is considered a major advantage as compared with PE which often requires several rounds over several days to achieve a sufficient DSA reduction Within a few hours after imlifidase dosing the entire pool of IgG is completely cleaved and thereby a window where IgG levels are kept very low for approximately one week is created
The short-term efficacy and safety of imlifidase in active and chronic active AMR is being investigated in a randomized open-label multi-centre trial using PE as an active control ie the feeder study 16-HMedIdeS-12 A total of 30 subjects will be included in this study 20 in the imlifidase arm and 10 in the plasma exchange arm The primary objective is to investigate the efficacy of imlifidase in removing DSA in patients who are experiencing an AMR episode after kidney transplantation
While a rapid removal of DSA by imlifidase might be expected DSA is likely to rebound unless well-controlled by concomitant immunosuppressive therapy Therefore there is also a need to address the long-term outcome of imlifidase as an AMR therapy This will be studied during an extended follow-up period of 3 years in this study Data for parameters such as kidney graft survival patient survival kidney function treatment of rebound of donor specific antibodies DSA and anti-drug antibodies ADAs will be collected
The time from transplantation to onset of clinical symptoms of AMR varies largely between individuals An early AMR 30 days post-transplant is commonly classified as active AMR and most often triggered by an immunological recall response with pre-existing DSA A late AMR 30 days post-transplant is classified as either active or chronic active AMR and is caused by either a recall DSA response or newly developing naïve immune response associated with de novo DSA production
There is no currently approved therapy for AMR and patients are often treated with a combination of therapies ie high dose IVIg - rituximab PE with low dose IVIg - rituximab and eculizumab which makes analysis of efficacy of any single agent difficult Hence there is a large unmet clinical need for new therapies to treat AMR
Imlifidase is an IgG-degrading enzyme of Streptococcus pyogenes that cleaves all four human subclasses of IgG with high efficacy and specificity The rapidity of the IgG cleavage by imlifidase is considered a major advantage as compared with PE which often requires several rounds over several days to achieve a sufficient DSA reduction Within a few hours after imlifidase dosing the entire pool of IgG is completely cleaved and thereby a window where IgG levels are kept very low for approximately one week is created
The short-term efficacy and safety of imlifidase in active and chronic active AMR is being investigated in a randomized open-label multi-centre trial using PE as an active control ie the feeder study 16-HMedIdeS-12 A total of 30 subjects will be included in this study 20 in the imlifidase arm and 10 in the plasma exchange arm The primary objective is to investigate the efficacy of imlifidase in removing DSA in patients who are experiencing an AMR episode after kidney transplantation
While a rapid removal of DSA by imlifidase might be expected DSA is likely to rebound unless well-controlled by concomitant immunosuppressive therapy Therefore there is also a need to address the long-term outcome of imlifidase as an AMR therapy This will be studied during an extended follow-up period of 3 years in this study Data for parameters such as kidney graft survival patient survival kidney function treatment of rebound of donor specific antibodies DSA and anti-drug antibodies ADAs will be collected
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004777-49 | EUDRACT_NUMBER | None | None |