Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys
- Conditions
- Kidney Transplantation in Highly Sensitized Patients
- Interventions
- Other: Best available treatment administered in the ConfIdeS study
- Registration Number
- NCT05714514
- Lead Sponsor
- Hansa Biopharma AB
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- Signed Informed Consent obtained before any trial-related procedures.
- Previous participation in the clinical trial ConfIdeS.
- Inability by the judgement of the investigator to participate in the trial for any reason.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Imlifidase administered in the ConfIdeS study Imlifidase administered in the ConfIdeS study - Best available treatment administered in the ConfIdeS study Best available treatment administered in the ConfIdeS study -
- Primary Outcome Measures
Name Time Method Proportion of patients alive and free of dialysis at 3 years 3 years after randomization in the ConfIdeS study
- Secondary Outcome Measures
Name Time Method 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
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
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
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.
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
Trial Locations
- Locations (10)
Northwestern University, Dept. General Surgery, Div. Transplantation
🇺🇸Chicago, Illinois, United States
University of Alabama at Birmingham (UAB) Hospital
🇺🇸Birmingham, Alabama, United States
John Hopkins Hospital
🇺🇸Baltimore, Maryland, 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
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Methodist Hospital Specialty and Transplant
🇺🇸San Antonio, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States