Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts
Lead Sponsor:
Hansa Biopharma AB
Conditions:
Kidney Transplantation in Highly Sensitized Patients
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) a...
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will undergo pre-screening to determine eligibility for study entry. All highly sensitized ESRD p...
Eligibility Criteria
Inclusion
- Inclusion criteria for ALL patients
- Male or female patient aged 18-75 years
- ABO-compatible deceased donor aged 10-70 years
- Inclusion criteria for IMLIFIDASE patients
- ESRD active on the renal transplant waiting list of a kidney allocation system at the time of screening
- High sensitization with the highest unmet medical need unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitized patients
- Known DSA against an available deceased donor
- Positive crossmatch test determined by complement-dependent cytotoxicity crossmatch (CDCXM) and/or flow cytometric crossmatch (FCXM) against an available deceased donor. If physical XM tests are not practically possible due to lack of time, patients may be included on a virtual crossmatch (vXM) predictive of a positive XM test.
- Signed Informed Consent obtained before any trial-related procedures
- Willingness and ability to comply with the protocol
- Inclusion criteria for patients in the NON-COMPARATIVE CONCURRENT REFERENCE COHORT
- Active on the renal transplant waiting list at a participating trial site at the time of screening
- An acceptable kidney transplant from a deceased donor
- Signed Informed Consent obtained before any trial related procedures
- Willingness and ability to comply with the protocol
- Inclusion criteria for patients in the NON-COMPARATIVE HISTORICAL REFERENCE COHORT
- ESRD with a kidney transplant from a deceased donor
- Being transplanted in Europe after 01-Jan-2010 and included in the CTS registry
- Panel reactive antibodies (PRA) ≥ 50% (CDC T- or B-cell PRA, calculated panel reactive antibodies (cPRA), or virtual panel reactive antibodies (vPRA))
- Maintenance immunosuppression (intention to treat) with calcineurin inhibitor, mycophenolate mofetil (MMF) and corticosteroids in combination
Exclusion
- Exclusion criteria for IMLIFIDASE patients and for patients in the NON-COMPARATIVE CONCURRENT REFERENCE COHORT
- Use of investigational agents within 5 terminal elimination half-lives prior to the transplantation
- Malignancy within 5 years prior to transplantation
- Positive serology for human immunodeficiency virus (HIV)
- Clinically relevant active infection(s) as judged by the investigator
- Contemporaneous participation in medical device studies
- Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the trial activities
- Inability by the judgement of the investigator to participate in the trial for any other reason
- Exclusion criteria for IMLIFIDASE patients
- Previous treatment with imlifidase
- Previous high dose IVIg treatment (2 g/kg) within 28 days prior to imlifidase treatment
- Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
- Breast feeding or pregnancy
- Hypersensitivity to the active substance (imlifidase) or to any of the excipients
- Ongoing serious infections
- Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
- Severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent respiratory disease
- Female of childbearing potential, not willing to use effective contraception during the 3 weeks following treatment with imlifidase. In the context of this trial, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; (i) oral, (ii) intravaginal, or (iii) transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation; (i) oral, (ii) injectable, or (iii) implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- true abstinence: When this is in line with the preferred and usual lifestyle of the patient. \[Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\]
- Any other reason that, in the view of the investigator, precludes transplantation
- Exclusion criteria for patients in the NON-COMPARATIVE HISTORICAL REFERENCE COHORT
- Patients treated with mammalian target of rapamycin (mTOR) inhibitors
- Patients treated with belatacept
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05369975
Start Date
April 19 2022
End Date
April 1 2026
Last Update
March 18 2025
Active Locations (22)
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1
Medizinische Universitaet Wien
Vienna, Austria, 1090
2
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
3
Institut klinicke a experimentalni mediciny (IKEM)
Prague, Czechia, 140-21
4
Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume
Bois-Guillaume, France, 76230