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NCT Number: NCT03611621

A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these subjects. Data of parameters such as patient and graft survival, comorbidity, treatment of graft rejection episodes and quality of life as well as anti-drug antibody levels will be collected.

This prospective, observational follow up study of subjects who have received imlifidase prior to kidney transplantation will provide important data to future prescribers and patients of the potential long-term benefits of imlifidase mediated transplantation.

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Key information

Conditions

Kidney Transplant Failure and Rejection Behavior Rejection, Psychology Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker Hospital, Paris, France

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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 study-related procedures
  • Previous dosing with imlifidase followed by kidney transplantation and participation in one of the following clinical studies: 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 or 15-HMedIdeS-06

Exclusion criteria

  • Individuals deemed unable to comply with the protocol
  • Inability by the judgment of the investigator to participate in the study for other reasons

Treatment and study plan

Imlifidase

Drug

This is a five year, long-term follow up, observational study. The study will primarily determine the time of graft survival in subjects who have received imlifidase prior to kidney transplantation. Subjects who have participated, or are currently participating, in the imlifidase kidney transplantation studies (called feeder studies) 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS- 04 and 15-HMedIdeS-06 will be included. The subjects will attend 4 follow up visits, 1, 2, 3 and 5 years after imlifidase administration.

Other names: IdeS, HMED-IdeS

Primary outcomes

  1. Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.

Secondary outcomes

  1. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival.

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Overall patient survival defined as time from transplantation to death for any cause

  2. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)).

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation.

  3. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine).

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Kidney function as evaluated by analysis of plasma (P)-creatinine

  4. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Kidney function as evaluated by proteinuria by dipstick analysis

  5. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes.

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Recording of occurrence of graft rejection episodes classified by Banff criteria (Haas et al 2018).

    The following criteria had to be fulfilled by the rejection episode to constitute an antibody-mediated rejection (AMR):

    • a biopsy was taken at the time of the graft rejection episode
    • histological evidence of an AMR was reported in the pathology report
    • presence of detectable levels of donor specific antibodies (DSAs) and/or evidence of antibody-mediated morphological changes in the kidney transplant at the time of the biopsy

  6. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes.

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications).

  7. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Recording of comorbidities up until year 5 after treatment with imlifidase

  8. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.

    Time frame: 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5

    Recording of concomitant immunosuppressive medication

  9. Assessment of Safety Laboratory Testing in Terms of Hematology (Hb)

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Blood samples were analyzed for hemoglobulin (Hb)

  10. Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Differential analysis of leucocytes was done in blood samples

  11. Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Blood samples were analyzed for thrombocytes

  12. Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Blood samples were analyzed for total IgG levels.

  13. Assessment of Donor Specific Antibodies (DSA)

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    DSA levels in blood samples were analyzed by Single Antigen Bead-Human Leukocyte Antigen (SAB-HLA) analysis

  14. Assessment of the Presence of BK Virus

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Blood samples were analyzed for antibodies towards BK virus

  15. Assessment of the Immunogenicity of Imlifidase

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Serum samples were analyzed for anti-drug antibody (ADA) levels using an ImmunoCAP assay.

  16. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5 levels (5L)

    EQ-5D-5L index score values were calculated from individual health profiles by using the corresponding EQ-5D-5L crosswalk value set per country where a higher value correspond to better health. Index score value ranges per country: USA [-0.109 - 1.000], France [-0.530 - 1.000], Denmark [-0.624 - 1.000], since no index score values exist for Sweden, values for Denmark were used for patients from Sweden.

    The visual analogue scale (EQ VAS) score was graded from 0 (the worst imaginable health) to 100 (the best imaginable health), where higher scores correspond to better health.

  17. Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).

    Time frame: 5 years after first dose of imlifidase (in the feeder study)

    Health related quality of life (HR-QoL) as evaluated by patient questionnaires Kidney Disease Quality of Life Questionnaire-short form (KDQOL-SF)

    Scores of different subscales were calculated according to the KDQOL-36 scoring program. The scale range for each subscale is 0 to 100, with higher scores indicating better quality of life.

Sponsors and collaborators

Lead sponsor

Hansa Biopharma AB

Industry

Registry information

Official study title

A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2018
Registry last updated
Feb 7, 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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