2022-502727-21-00
Recruiting
Phase 3
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
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Hansa Biopharma AB
- Enrollment
- 126
- Locations
- 16
- Primary Endpoint
- Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation(imlifidase cohort only)
Overview
Brief Summary
To evaluate long-term graft failure-free survival in highly sensitised kidney transplant patients after imlifidase administration in trial 20-MedIdeS-19 (PAES) (imlifidase cohort only)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation(imlifidase cohort only)
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation(imlifidase cohort only)
Secondary Outcomes
- Graft failure-free survival (%) up to 5 years after transplantation (non-comparativeconcurrent reference cohort only)
- Graft failure-free survival (%) up to 2 and 3 years after transplantation
- Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) andserum/plasma creatinine levels
- Patient survival (%) after transplantation
- Graft survival (%) after transplantation
- HLA/DSA levels (imlifidase cohort only)
- ADA levels (imlifidase cohort only)
- Proportion of patients (%) with biopsy- and serology (DSA)-confirmed AMRs
- Proportion of patients (%) with biopsy confirmed CMRs.
- Treatment of graft rejection episodes
- Adverse events (AEs)/serious adverse events (SAEs) suspected to be related toimlifidase treatment (imlifidase cohort only)
- Ongoing immunosuppressive medication
- Comorbidity
- Change in patient reported life participation, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain “Ability to participate in social roles & activities, PROMIS-SF-8a”, from baseline to 5 years after transplantation
Investigators
Clinical contact information
Scientific
Hansa Biopharma AB
Study Sites (16)
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