EUCTR2021-002640-70-ES进行中（未招募）1 期
A controlled, open-label post-authorisation efficacy and safety study in imlifidase desensitised kidney transplant patients with positive crossmatch against a deceased donor prior to imlifidase treatment, including non-comparative registry and concurrent reference cohorts
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for all patients
- •1. Male or female patient aged 18-75 years
- •2. ABO-compatible deceased donor aged 10-70 years
- •Inclusion Criteria for imlifidase patients
- •1. End-stage renal disease (ESRD) active on the renal transplant waiting list of a kidney allocation system at the time of screening
- •2. High sensitisation with the highest unmet medical need unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients (see table below)
- •3. Known DSA against an available deceased donor
- •4. Positive crossmatch test determined by Complement-Dependent Cytotoxicity crossmatch (CDCXM) and/or Flow Cytometry Crossmatch (FCXM) against an available deceased donor. If physical crossmatch tests are not practically possible due to lack of time, patients may be included on a Virtual Crossmatch (vXM) predictive of a positive crossmatch test.
- •5. Signed Informed Consent obtained before any trial-related procedures
- •6. Willingness and ability to comply with the protocol
- •Recommended reference thresholds for highest unmet medical need
- •depending on sensitisation within different European allocation system (see protocol)
- •Inclusion Criteria for patients in the non-comparative concurrent reference cohort
- •1. Active on the renal transplant waiting list at a participating trial site at the time of screening
- •2. An acceptable kidney transplant from a deceased donor
- •3. Signed Informed Consent obtained before any trial related procedures
- •4. Willingness and ability to comply with the protocol
- •Inclusion Criteria for patients in the non-comparative historical reference cohort
- •1. End-stage renal disease with a kidney transplant from a deceased donor
- •2. Being transplanted in Europe after 01-Jan-2010 and included in the CTS registry
- •3. PRA = 50% (CDC T or B cell PRA, cPRA, or virtual PRA [vPRA])
- •4. Maintenance immunosuppression (intention to treat) with calcineurin inhibitor, mycophenolate mofetil (MMF) and corticosteroids in combination
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Exclusion Criteria for imlifidase patients and for patients in the noncomparative concurrent reference cohort
- •1. Use of investigational agents within 5 terminal elimination half-lives prior to the transplantation
- •2. Malignancy within 5 years prior to transplantation
- •3. Positive serology for human immunodeficiency virus (HIV)
- •4. Clinically relevant active infection(s) as judged by the investigator
- •5. Contemporaneous participation in medical device studies
- •6. Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the trial activities
- •7. Inability by the judgement of the investigator to participate in the trial for any other reason
- •Exclusion Criteria for imlifidase patients
- •1. Previous treatment with imlifidase
- •2. Previous high dose IVIg treatment (2 g/kg) within 28 days prior to imlifidase treatment
- •3. Positive SARS-CoV-2 test
- •4. Breast feeding or pregnancy
- •5. Hypersensitivity to the active substance (imlifidase) or to any of the excipients (see section 5.1)
- •6. Ongoing serious infections
- •7. Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
- •8. 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
- •9. 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.
- •10. Any other reason that, in the view of the investigator, precludes transplantation
- •Exclusion Criteria for patients in the non-comparative historical reference cohort
- •1. Patients treated with mTOR (mammalian target of rapamycin) inhibitors
- •2. Patients treated with belatacept
研究者
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