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A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group

  • A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.

NCT_ID: NCT05937750

Clinical Trial Link

Brief Summaries

Sequence: 30605064
Description A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.

Studies

Study First Submitted Date 2023-06-13
Study First Posted Date 2023-07-10
Last Update Posted Date 2023-07-19
Start Month Year July 3, 2023
Primary Completion Month Year December 31, 2028
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-19

Detailed Descriptions

Sequence: 20615147
Description This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test. The purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data.

Facilities

Sequence: 199013927
Status Recruiting
Name Hospital Universitario del Vall d´Hebron
City Barcelona
Zip 08035
Country Spain

Facility Contacts

Sequence: 27986650
Facility Id 199013927
Contact Type primary
Name O Bestard, MD
Email oriol.bestard@vallhebron.cat

Facility Investigators

Sequence: 18257927
Facility Id 199013927
Role Principal Investigator
Name O Bestrad

Conditions

Sequence: 51899167
Name Long Term Efficacy and Safety
Downcase Name long term efficacy and safety

Id Information

Sequence: 39944962
Id Source org_study_id
Id Value 20-HMedIdeS-20

Countries

Sequence: 42337167
Name Spain
Removed False

Design Groups

Sequence: 55309830 Sequence: 55309831
Group Type Experimental Group Type Experimental
Title Imlifidase Title Non-Comparative Concurrent Reference Cohort
Description Imlifidase administered in the 20-HMedIdeS-19 (PAES) study Description Best available treatment administered in the 20-HMedIdeS-19 (PAES) study

Interventions

Sequence: 52214702 Sequence: 52214703
Intervention Type Drug Intervention Type Other
Name Imlifidase administered in the 20-HMedIdeS-19 (PAES) study Name Best available treatment administered in the 20-HMedIdeS-19 (PAES) study
Description 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. Description Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.

Keywords

Sequence: 79434132 Sequence: 79434133
Name Renal transplantation Name Kidney transplantation
Downcase Name renal transplantation Downcase Name kidney transplantation

Design Outcomes

Sequence: 176452493 Sequence: 176452494 Sequence: 176452495 Sequence: 176452496 Sequence: 176452497 Sequence: 176452498 Sequence: 176452499 Sequence: 176452500 Sequence: 176452501 Sequence: 176452502 Sequence: 176452503 Sequence: 176452504 Sequence: 176452505 Sequence: 176452506 Sequence: 176452507 Sequence: 176452508 Sequence: 176452509
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only) Measure Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only) Measure Graft failure-free survival (%) up to 2 and 3 years after transplantation Measure Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels Measure Patient survival (%) after transplantation Measure Graft survival (%) after transplantation Measure Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only) Measure Anti-drug antibody (ADA) levels (imlifidase cohort only) Measure Proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs) Measure Proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs) Measure Treatment of graft rejections Measure Treatment of graft rejection Measure Treatment of graft rejection Measure Adverse events (AEs)/serious adverse events (SAEs) suspected to be related to imlifidase treatment (imlifidase cohort only) Measure Use of immunosuppressive medication Measure Comorbidities Measure Change in patient reported life participation
Time Frame 5-years after transplantation Time Frame 5-years after transplantation Time Frame 2 and 3-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation Time Frame 2, 3, and 5-years after transplantation
Description Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft. The 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable. Description Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft. The 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable. Description Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft. The 2 and 3-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable. Description Kidney function assessed by eGFR and serum/plasma creatinine will be summarised over 5 years for the imlifidase group and the reference cohort. eGFR is a measure of kidney function. The serum/plasma creatinine levels will be analysed and eGFR will be calculated according to the modification of diet in renal disease (MDRD) equation. Reduced kidney function is characterised by a decreased eGFR value. For patients in the imlifidase group who are not successfully transplanted, or for any enrolled patients without a functioning graft, their eGFR values will be set to 0 mL/min. Description Patient survival up to 2, 3 and 5 years, respectively, will be assessed for the imlifidase group and the reference cohort. The 2, 3, and 5-year patient survival rates will be extracted from Kaplan-Meier curves. Description Graft survival up to 2, 3 and 5 years, respectively, will be assessed for the imlifidase group and the reference cohort. Graft survival will be presented with Kaplan-Meier curves. Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients who die will be censored at time of death. Description HLA antibodies will be analysed using an IgG single antigen solid-phase immunoassay for class I and class II (SAB-HLA). Donor specific antibodies (DSAs) are identified by using the human leukocyte antigen (HLA) profile data from the donor and the recipient to identify HLA-mismatches. The mean fluorescence intensity (MFI) will be summarized for all DSAs with an MFI of ≥1000 at any time during the trial (or the PAES trial). Description Determination of anti-imlifidase IgG (ADA) concentration in serum will be performed centrally using a customised ImmunoCAP to evaluate imlifidase long-term immunogenicity. Description For-cause biopsies will be obtained to confirm diagnosis for suspected AMRs in both treatment arms. The biopsies will be analysed locally and centrally and evaluated according to Banff criteria version 2017 or later. Description For-cause biopsies will be obtained to confirm diagnosis for suspected CMRs in both treatment arms. The biopsies will be analysed locally and centrally and evaluated according to Banff criteria version 2017 or later. Description The number of graft rejection episodes treated with dialysis will be recorded Description The number of graft rejection episodes treated with plasmapheresis will be recorded Description The number of graft rejection episodes treated with medication will be recorded Description AEs/SAEs suspected to be related to imlifidase treatment in the PAES trial will be recorded from the time of signed informed consent for participation in the trial until the last trial visit. Description The patient's use of immunosuppressive medications will be recorded for both cohorts from the time of signed informed consent for participation in the trial until the last trial visit. Description Information about comorbidities that are medically relevant and registered in the patient' medical record will be collected. Medically relevant comorbidities are infections, malignancy, diabetes mellitus and cardiovascular events. Description The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain "Ability to participate in social roles & activities, PROMIS-SF-8a" will be used as a measure of the patients' health related quality of life. The questionnaire includes 8 questions about a persons ability to participate in different social activities and there are 5 different answers to choose from for each question: Never/Rarely/Sometimes/Usually/Always

Sponsors

Sequence: 48063311
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Hansa Biopharma AB

Overall Officials

Sequence: 29125012
Role Study Director
Name Clinical Operations
Affiliation Hansa Biopharma AB

Central Contacts

Sequence: 11949906
Contact Type primary
Name Central Contact
Phone +46 46 16 56 70
Email clinicalstudyinfo@hansabiopharma.com
Role Contact

Design Group Interventions

Sequence: 67806628 Sequence: 67806629
Design Group Id 55309830 Design Group Id 55309831
Intervention Id 52214702 Intervention Id 52214703

Eligibilities

Sequence: 30603845
Gender All
Minimum Age 19 Years
Maximum Age 76 Years
Healthy Volunteers No
Criteria Inclusion Criteria: Signed Informed Consent obtained before any trial-related procedures Willingness and ability to comply with the protocol Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES) Exclusion Criteria: Inability by the judgment of the investigator to participate in the trial for other reasons
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253920260
Number Of Facilities 1
Registered In Calendar Year 2023
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 19
Maximum Age Num 76
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 16

Designs

Sequence: 30351206
Allocation Non-Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Other
Time Perspective
Masking None (Open Label)
Intervention Model Description This is a long-term follow-up trial following an open-label, non-randomized trial in highly sensitized adult kidney transplant patients with positive crossmatch (XM) against an available deceased donor. The rational for the main trial, 20-HMedIdeS-19 (PAES), being non-randomized is that no other effective or approved desensitization protocol exists in deceased-donor kidney transplantation that would provide a suitable control. A non-comparative concurrent reference cohort from participating sites was included to address differences in-site practice and experience.

Intervention Other Names

Sequence: 26542735 Sequence: 26542736 Sequence: 26542737
Intervention Id 52214702 Intervention Id 52214702 Intervention Id 52214702
Name IdeS Name HMED-IdeS Name Idefirix

Responsible Parties

Sequence: 28724573
Responsible Party Type Sponsor

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