Kidney Transplantation in Highly Sensitized Patients
Conditions
Keywords
Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Renal transplantation, Deceased donor
Brief summary
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).
Detailed 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.
Interventions
DRUGImlifidase administered in the ConfIdeS study
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.
OTHERBest available treatment administered in the ConfIdeS study
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
Sponsors
Hansa Biopharma AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Signed Informed Consent obtained before any trial-related procedures. 2. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients alive and free of dialysis at 3 years | 3 years after randomization in the ConfIdeS study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients alive at 3 and 5 years | 3 and 5 years after randomization in the ConfIdeS study | — |
| Graft failure-free survival rates at 3 and 5 years | 3 and 5 years after randomization in the ConfIdeS study | Graft failure-free survival is defined as time from randomization to the fist of either graft failure or death |
| Graft survival rates at 3 and 5 years | 3 and 5 years after randomization in the ConfIdeS study | To be assessed in patients who were transplanted at randomization in the ConfIdeS study |
| Number of patients per wait-list category | 3 and 5 years after randomization in the ConfIdeS study | The different wait-list categories are: transplanted, active, temporary inactive, inactive, or deceased |
| Proportion of patients alive and free of dialysis at 5 years | 5 years after randomization in the ConfIdeS study | — |
| Proportion of patients with biopsy- and serology confirmed antibody-mediated rejection (AMR) | 3 and 5 years after randomization in the ConfIdeS study | — |
| Proportion of patients with biopsy confirmed cell-mediated rejection | 3 and 5 years after randomization in the ConfIdeS study | — |
| Treatment of graft rejection episodes | 3 and 5 years after randomization in the ConfIdeS study | Any treatments given during rejection episodes will be recorded |
| Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years | 3 and 5 years after randomization in the ConfIdeS study | 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. |
Countries
United States
Outcome results
None listed