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NCT Number: NCT05714514

Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys

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).

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Key information

Conditions

Kidney Transplantation in Highly Sensitized Patients

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham (UAB) Hospital, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent obtained before any trial-related procedures.
  • Previous participation in the clinical trial ConfIdeS.

Exclusion criteria

  • Inability by the judgement of the investigator to participate in the trial for any reason.

Treatment and study plan

Imlifidase administered in the ConfIdeS study

Drug

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

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

Primary outcomes

  1. Proportion of patients alive and free of dialysis at 3 years

    Time frame: 3 years after randomization in the ConfIdeS study

Secondary outcomes

  1. Proportion of patients alive and free of dialysis at 5 years

    Time frame: 5 years after randomization in the ConfIdeS study

  2. Proportion of patients alive at 3 and 5 years

    Time frame: 3 and 5 years after randomization in the ConfIdeS study

  3. Graft failure-free survival rates at 3 and 5 years

    Time frame: 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

  4. Graft survival rates at 3 and 5 years

    Time frame: 3 and 5 years after randomization in the ConfIdeS study

    To be assessed in patients who were transplanted at randomization in the ConfIdeS study

  5. Number of patients per wait-list category

    Time frame: 3 and 5 years after randomization in the ConfIdeS study

    The different wait-list categories are: transplanted, active, temporary inactive, inactive, or deceased

  6. Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years

    Time frame: 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.

  7. Proportion of patients with biopsy- and serology confirmed antibody-mediated rejection (AMR)

    Time frame: 3 and 5 years after randomization in the ConfIdeS study

  8. Proportion of patients with biopsy confirmed cell-mediated rejection

    Time frame: 3 and 5 years after randomization in the ConfIdeS study

  9. Treatment of graft rejection episodes

    Time frame: 3 and 5 years after randomization in the ConfIdeS study

    Any treatments given during rejection episodes will be recorded

Sponsors and collaborators

Lead sponsor

Hansa Biopharma AB

Industry

Registry information

Official study 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

Acronym: ConfIdeSLTFU

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Feb 6, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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