NCT_ID: NCT05714514
Clinical Trial Link
Brief Summaries
Sequence: | 30947511 |
Description | The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177). |
Studies
Study First Submitted Date | 2023-01-27 |
Study First Posted Date | 2023-02-06 |
Last Update Posted Date | 2023-06-15 |
Start Month Year | April 21, 2023 |
Primary Completion Month Year | December 31, 2027 |
Verification Month Year | June 2023 |
Verification Date | 2023-06-30 |
Last Update Posted Date | 2023-06-15 |
Detailed Descriptions
Sequence: | 20844785 |
Description | This is an observational follow-up study subsequent to the ConfIdeS study (20-HMedIdeS-17, NCT04935177) in highly sensitized patients who were randomized to imlifidase or SoC desensitization prior to kidney transplantation with a deceased donor graft, or, if SoC perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer. After the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the ConfIdeS study. Most of the assessments in this study are already part of the follow up within SoC for these patients. During the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the ConfIdeS study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated. |
Facilities
Sequence: | 201220196 | Sequence: | 201220197 | Sequence: | 201220198 | Sequence: | 201220199 | Sequence: | 201220200 | Sequence: | 201220201 |
Status | Not yet recruiting | Status | Not yet recruiting | Status | Recruiting | Status | Recruiting | Status | Not yet recruiting | Status | Not yet recruiting |
Name | University of Alabama at Birmingham (UAB) Hospital | Name | John Hopkins Hospital | Name | New York University (NYU) Langone Transplant Institute | Name | Columbia University | Name | Houston Methodist Hospital | Name | Methodist Hospital Specialty and Transplant |
City | Birmingham | City | Baltimore | City | New York | City | New York | City | Houston | City | San Antonio |
State | Alabama | State | Maryland | State | New York | State | New York | State | Texas | State | Texas |
Zip | 35249 | Zip | 21287 | Zip | 10016 | Zip | 10032 | Zip | 77030 | Zip | 78229 |
Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Facility Contacts
Sequence: | 28272449 | Sequence: | 28272450 | Sequence: | 28272451 | Sequence: | 28272452 | Sequence: | 28272453 | Sequence: | 28272454 |
Facility Id | 201220196 | Facility Id | 201220197 | Facility Id | 201220198 | Facility Id | 201220199 | Facility Id | 201220200 | Facility Id | 201220201 |
Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
Name | Douglas Anderson, MD | Name | N Desai, MD | Name | Bonnie A Lonze, MD | Name | Lloyd Ratner, MD | Name | Osama Gaber, MD | Name | Matthias Kapturczak, MD |
douglasanderson@uabmc.edu | ndesai13@jhmi.edu | Bonnie.Lonze@nyulangone.org | lr2182@cumc.columbia.edu | AOGaber@houstonmethodist.org | matthias.kapturczak@hcahealthcare.com | ||||||
Facility Investigators
Sequence: | 18433620 | Sequence: | 18433621 | Sequence: | 18433622 | Sequence: | 18433623 | Sequence: | 18433624 | Sequence: | 18433625 |
Facility Id | 201220196 | Facility Id | 201220197 | Facility Id | 201220198 | Facility Id | 201220199 | Facility Id | 201220200 | Facility Id | 201220201 |
Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
Name | Douglas Anderson, MD | Name | N Desai, MD | Name | Bonnie Lonze, MD | Name | Lloyd Ratner, MD | Name | A Gaber | Name | Matthias Kapturczak, MD |
Conditions
Sequence: | 52487110 |
Name | Kidney Transplantation in Highly Sensitized Patients |
Downcase Name | kidney transplantation in highly sensitized patients |
Id Information
Sequence: | 40384474 |
Id Source | org_study_id |
Id Value | 21-HMedIdes-25 |
Countries
Sequence: | 42820074 |
Name | United States |
Removed | False |
Design Groups
Sequence: | 55943317 | Sequence: | 55943318 |
Title | Imlifidase administered in the ConfIdeS study | Title | Best available treatment administered in the ConfIdeS study |
Interventions
Sequence: | 52796144 | Sequence: | 52796145 |
Intervention Type | Drug | Intervention Type | Other |
Name | Imlifidase administered in the ConfIdeS study | Name | Best available treatment administered in the ConfIdeS study |
Description | Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc- fragment and efficiently neutralizes Fc-mediated activities of IgG. | Description | Institution-specific desensitization treatment prior to kidney transplantation in the ConfIdeS study OR remain on wait list for a more compatible organ offer if desensitization with institutional protocol is not appropriate |
Keywords
Sequence: | 80297076 | Sequence: | 80297077 | Sequence: | 80297078 | Sequence: | 80297079 | Sequence: | 80297080 | Sequence: | 80297081 |
Name | Desensitization | Name | Highly sensitized | Name | Positive crossmatch | Name | Unlikely to be transplanted | Name | Renal transplantation | Name | Deceased donor |
Downcase Name | desensitization | Downcase Name | highly sensitized | Downcase Name | positive crossmatch | Downcase Name | unlikely to be transplanted | Downcase Name | renal transplantation | Downcase Name | deceased donor |
Design Outcomes
Sequence: | 178562747 | Sequence: | 178562748 | Sequence: | 178562749 | Sequence: | 178562750 | Sequence: | 178562751 | Sequence: | 178562752 | Sequence: | 178562753 |
Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
Measure | Proportion of patients alive and free of dialysis at 3 years | Measure | Proportion of patients alive and free of dialysis at 5 years | Measure | Proportion of patients alive at 3 and 5 years | Measure | Graft failure-free survival rates at 3 and 5 years | Measure | Graft survival rates at 3 and 5 years | Measure | Number of patients per wait-list category | Measure | Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years |
Time Frame | 3 years after randomization in the ConfIdeS study | Time Frame | 5 years after randomization in the ConfIdeS study | Time Frame | 3 and 5 years after randomization in the ConfIdeS study | Time Frame | 3 and 5 years after randomization in the ConfIdeS study | Time Frame | 3 and 5 years after randomization in the ConfIdeS study | Time Frame | 3 and 5 years after randomization in the ConfIdeS study | Time Frame | 3 and 5 years after randomization in the ConfIdeS study |
Description | Graft failure-free survival is defined as time from randomization to the fist of either graft failure or death | Description | To be assessed in patients who were transplanted at randomization in the ConfIdeS study | Description | The different wait-list categories are: transplanted, active, temporary inactive, inactive, or deceased | Description | eGFR is a measure of kidney function. eGFR will be calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. Kidney disease is characterised by a decreased eGFR value. eGFR will be set to zero, for randomized patients who do not undergo transplantation, lose their graft or die. |
Sponsors
Sequence: | 48612620 |
Agency Class | INDUSTRY |
Lead Or Collaborator | lead |
Name | Hansa Biopharma AB |
Overall Officials
Sequence: | 29450568 |
Role | Study Director |
Name | Therese Åkerfeldt |
Affiliation | Hansa Biopharma AB |
Central Contacts
Sequence: | 12090347 |
Contact Type | primary |
Name | Central Contact |
Phone | +46 46 16 56 70 |
clinicalstudyinfo@hansabiopharma.com | |
Role | Contact |
Design Group Interventions
Sequence: | 68580746 | Sequence: | 68580747 |
Design Group Id | 55943317 | Design Group Id | 55943318 |
Intervention Id | 52796144 | Intervention Id | 52796145 |
Eligibilities
Sequence: | 30946292 |
Sampling Method | Non-Probability Sample |
Gender | All |
Minimum Age | N/A |
Maximum Age | N/A |
Healthy Volunteers | No |
Population | Patients who have participated in the clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177) |
Criteria | Inclusion Criteria: Signed Informed Consent obtained before any trial-related procedures. Previous participation in the clinical trial ConfIdeS. Exclusion Criteria: 1. Inability by the judgement of the investigator to participate in the trial for any reason. |
Adult | True |
Child | True |
Older Adult | True |
Calculated Values
Sequence: | 254313340 |
Number Of Facilities | 6 |
Registered In Calendar Year | 2023 |
Were Results Reported | False |
Has Us Facility | True |
Has Single Facility | False |
Number Of Primary Outcomes To Measure | 1 |
Number Of Secondary Outcomes To Measure | 6 |
Designs
Sequence: | 30691890 |
Observational Model | Cohort |
Time Perspective | Prospective |
Intervention Other Names
Sequence: | 26828743 |
Intervention Id | 52796144 |
Name | IdeS, HMED-IdeS |
Responsible Parties
Sequence: | 29058639 |
Responsible Party Type | Sponsor |