- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05937750
A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group (PAES-LTFU)
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
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Central Contact
- Phone Number: +46 46 16 56 70
- Email: clinicalstudyinfo@hansabiopharma.com
Study Locations
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-
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Prague, Czechia, 140-21
- Recruiting
- Nephrology Clinic Vídeňská 1958/9
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Principal Investigator:
- Ondrej Viklický, MD
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Contact:
- Ondrej Viklický, MD
- Email: ondrej.viklicky@ikem.cz
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-
-
-
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitario del Vall d´Hebron
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Contact:
- O Bestard, MD
- Email: oriol.bestard@vallhebron.cat
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Principal Investigator:
- O Bestrad
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Barcelona, Spain, 08036
- Recruiting
- Unidad de Trasplante Renal
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Contact:
- F Diekmann, MD
- Email: fdiekman@clinic.cat
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Principal Investigator:
- F Diekmann, MD
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Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
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Contact:
- Amado Andres, MD
- Email: amado.andres@salud.madrid.org
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Principal Investigator:
- Amado Andres
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imlifidase
Imlifidase administered in the 20-HMedIdeS-19 (PAES) 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:
|
Experimental: Non-Comparative Concurrent Reference Cohort
Best available treatment administered in the 20-HMedIdeS-19 (PAES) study
|
Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)
Time Frame: 5-years after transplantation
|
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. |
5-years after transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only)
Time Frame: 5-years after transplantation
|
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. |
5-years after transplantation
|
Graft failure-free survival (%) up to 2 and 3 years after transplantation
Time Frame: 2 and 3-years after transplantation
|
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. |
2 and 3-years after transplantation
|
Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels
Time Frame: 2, 3, and 5-years after transplantation
|
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. |
2, 3, and 5-years after transplantation
|
Patient survival (%) after transplantation
Time Frame: 2, 3, and 5-years after transplantation
|
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. |
2, 3, and 5-years after transplantation
|
Graft survival (%) after transplantation
Time Frame: 2, 3, and 5-years after transplantation
|
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. |
2, 3, and 5-years after transplantation
|
Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only)
Time Frame: 2, 3, and 5-years after transplantation
|
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). |
2, 3, and 5-years after transplantation
|
Anti-drug antibody (ADA) levels (imlifidase cohort only)
Time Frame: 2, 3, and 5-years after transplantation
|
Determination of anti-imlifidase IgG (ADA) concentration in serum will be performed centrally using a customised ImmunoCAP to evaluate imlifidase long-term immunogenicity.
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2, 3, and 5-years after transplantation
|
Proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs)
Time Frame: 2, 3, and 5-years after transplantation
|
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. |
2, 3, and 5-years after transplantation
|
Proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs)
Time Frame: 2, 3, and 5-years after transplantation
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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. |
2, 3, and 5-years after transplantation
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Treatment of graft rejections
Time Frame: 2, 3, and 5-years after transplantation
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The number of graft rejection episodes treated with dialysis will be recorded
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2, 3, and 5-years after transplantation
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Treatment of graft rejection
Time Frame: 2, 3, and 5-years after transplantation
|
The number of graft rejection episodes treated with plasmapheresis will be recorded
|
2, 3, and 5-years after transplantation
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Treatment of graft rejection
Time Frame: 2, 3, and 5-years after transplantation
|
The number of graft rejection episodes treated with medication will be recorded
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2, 3, and 5-years after transplantation
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Adverse events (AEs)/serious adverse events (SAEs) suspected to be related to imlifidase treatment (imlifidase cohort only)
Time Frame: 2, 3, and 5-years after transplantation
|
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.
|
2, 3, and 5-years after transplantation
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Use of immunosuppressive medication
Time Frame: 2, 3, and 5-years after transplantation
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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.
|
2, 3, and 5-years after transplantation
|
Comorbidities
Time Frame: 2, 3, and 5-years after transplantation
|
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.
|
2, 3, and 5-years after transplantation
|
Change in patient reported life participation
Time Frame: 2, 3, and 5-years after transplantation
|
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 |
2, 3, and 5-years after transplantation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Operations, Hansa Biopharma AB
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-HMedIdeS-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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