A Prospective, Long-term Confirmatory Follow up Trial in Highly Sensitized Patients Treated With Imlifidase or Standard of Care in the ConfIdeS (20-HMedIdeS-17) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Imlifidase administered in the ConfIdeS study
- Conditions
- Kidney Transplantation in Highly Sensitized Patients
- Sponsor
- Hansa Biopharma AB
- Enrollment
- 64
- Locations
- 14
- Primary Endpoint
- Proportion of patients alive and free of dialysis at 3 years
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
Imlifidase administered in the ConfIdeS study
Intervention: Imlifidase administered in the ConfIdeS study
Best available treatment administered in the ConfIdeS study
Intervention: Best available treatment administered in the ConfIdeS study
Outcomes
Primary Outcomes
Proportion of patients alive and free of dialysis at 3 years
Time Frame: 3 years after randomization in the ConfIdeS study
Secondary Outcomes
- Number of patients per wait-list category(3 and 5 years after randomization in the ConfIdeS study)
- Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years(3 and 5 years after randomization in the ConfIdeS study)
- Proportion of patients alive and free of dialysis at 5 years(5 years after randomization in the ConfIdeS study)
- 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 survival rates at 3 and 5 years(3 and 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)