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).
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.
Study Type
OBSERVATIONAL
Enrollment
64
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.
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
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Proportion of patients alive and free of dialysis at 3 years
Time frame: 3 years after randomization in the ConfIdeS study
Proportion of patients alive and free of dialysis at 5 years
Time frame: 5 years after randomization in the ConfIdeS study
Proportion of patients alive at 3 and 5 years
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Graft failure-free survival rates at 3 and 5 years
Graft failure-free survival is defined as time from randomization to the fist of either graft failure or death
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Graft survival rates at 3 and 5 years
To be assessed in patients who were transplanted at randomization in the ConfIdeS study
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Number of patients per wait-list category
The different wait-list categories are: transplanted, active, temporary inactive, inactive, or deceased
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years
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.
Time frame: 3 and 5 years after randomization in the ConfIdeS study
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Northwestern University, Dept. General Surgery, Div. Transplantation
Chicago, Illinois, United States
University of Chicago, Department of Surgery, Clinical Research Center
Chicago, Illinois, United States
John Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
New York University (NYU) Langone Transplant Institute, NYU Langone Health
New York, New York, United States
Columbia University
New York, New York, United States
...and 4 more locations
Proportion of patients with biopsy- and serology confirmed antibody-mediated rejection (AMR)
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Proportion of patients with biopsy confirmed cell-mediated rejection
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Treatment of graft rejection episodes
Any treatments given during rejection episodes will be recorded
Time frame: 3 and 5 years after randomization in the ConfIdeS study