Clinical trial NCT05714514: Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplantation in Highly Sensitized Patients
Keywords: Desensitization
Highly sensitized
Positive crossmatch
Unlikely to be transplanted
Renal transplantation
Deceased donor
Lead sponsor: Hansa Biopharma AB
Sponsor class: INDUSTRY
First posted: 2023-02-06
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have participated in the clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients alive and free of dialysis at 3 years
timeFrame: 3 years after randomization in the ConfIdeS study
Secondary outcomes:
measure: Proportion of patients alive and free of dialysis at 5 years
timeFrame: 5 years after randomization in the ConfIdeS study
measure: Proportion of patients alive at 3 and 5 years
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
measure: Graft failure-free survival rates at 3 and 5 years
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
measure: Graft survival rates at 3 and 5 years
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
measure: Number of patients per wait-list category
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
measure: Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
measure: Proportion of patients with biopsy- and serology confirmed antibody-mediated rejection (AMR)
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
measure: Proportion of patients with biopsy confirmed cell-mediated rejection
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
measure: Treatment of graft rejection episodes
timeFrame: 3 and 5 years after randomization in the ConfIdeS study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB) Hospital
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University, Dept. General Surgery, Div. Transplantation
state: Illinois
city: Chicago
country: United States
facility: University of Chicago, Department of Surgery, Clinical Research Center
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Livingston
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University (NYU) Langone Transplant Institute, NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital Specialty and Transplant
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Hansa Biopharma AB
name: Therese Åkerfeldt
role: STUDY_DIRECTOR
References: