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Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys

  • 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).

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
Email douglasanderson@uabmc.edu Email ndesai13@jhmi.edu Email Bonnie.Lonze@nyulangone.org Email lr2182@cumc.columbia.edu Email AOGaber@houstonmethodist.org Email 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
Email 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

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