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Purpose

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).

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Imlifidase administered in the ConfIdeS study
  • Drug: Imlifidase 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.
    Other names:
    • IdeS, HMED-IdeS
Best available treatment administered in the ConfIdeS study
  • Other: Best 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

Recruiting Locations

University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama 35249
Contact:
Douglas Anderson, MD
douglasanderson@uabmc.edu

More Details

Status
Recruiting
Sponsor
Hansa Biopharma AB

Study Contact

Central Contact
+46 46 16 56 70
clinicalstudyinfo@hansabiopharma.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.