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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611621
Recruitment Status : Active, not recruiting
First Posted : August 2, 2018
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hansa Biopharma AB

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Kidney Transplant Failure and Rejection Drug: Imlifidase

Study Design
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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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Groups and Cohorts
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Intervention Details:
  • Drug: Imlifidase
    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 Name: IdeS, HMED-IdeS

Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of graft survival in subjects who have undergone kidney transplantation after imlifidase administration. [ Time Frame: 5 years after first dose of imlifidase ]
    The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.


Secondary Outcome Measures :
  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 ]
    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 (eGFR). [ Time Frame: 5 years after first dose of imlifidase ]
    Kidney function as evaluated by eGFR

  3. Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (P-creatinine). [ Time Frame: 5 years after first dose of imlifidase ]
    Kidney function as evaluated by 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 ]
    Kidney function as evaluated by proteinuria

  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 ]
    Record graft rejection episodes (classified by Banff, Haas et al 2018)

  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 ]
    Record graft rejection episodes treatments

  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 ]
    Record comorbidities

  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 ]
    Record concomitant immunosuppressive medication

  9. Assessment of safety laboratory testing in terms of hematology (Hb) [ Time Frame: 5 years after first dose of imlifidase ]
    Blood samples will be analysed 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 ]
    Differential analysis of leucocytes will be done in blood samples

  11. Assessment of safety laboratory testing in terms of hematology (thrombocytes) [ Time Frame: 5 years after first dose of imlifidase ]
    Blood samples will be analysed for thrombocytes

  12. Assessment of safety laboratory testing in terms of total IgG [ Time Frame: 5 years after first dose of imlifidase ]
    Blood samples will be analysed for total IgG levels.

  13. Assessment of donor specific antibodies (DSA) [ Time Frame: 5 years after first dose of imlifidase ]
    DSA levels in blood samples will be analysed by SAB-HLA

  14. Assessment of the presence of BK virus [ Time Frame: 5 years after first dose of imlifidase ]
    Blood samples will be analysed for antibodies towards BK virus

  15. Assessment of the immunogenicity of imlifidase [ Time Frame: 5 years after first dose of imlifidase ]
    Serum samples will be analysed 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 ]
    Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5L

  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 ]
    Health related quality of life (HR-QoL) as evaluated by patient questionnaires KDQOL-SF


Biospecimen Retention:   Samples With DNA
Blood samples (storage time: maximum 2 years after completion of the study report according to local regulations)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects that have participated, or are currently participating, in the imlifidase kidney transplantation studies; 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06 will be included.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611621


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
France
Necker Hospital
Paris, France, 75743
Sweden
Karolinska University Hospital
Stockholm, Sweden, 17176
Uppsala University Hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Hansa Biopharma AB
Investigators
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Study Director: Clinical Operations Hansa Biopharma AB
More Information
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Responsible Party: Hansa Biopharma AB
ClinicalTrials.gov Identifier: NCT03611621    
Other Study ID Numbers: 17-HMedIdeS-14
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No