EUCTR2021-002640-70-DE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
适应症
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 for recommended reference thresholds. Note: highest unmet medical need is per investigator's discretion)
- •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- •Inclusion Criteria for patients in the non-comparative historical reference cohort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 non-comparative 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) (including hepatitis B [HBV], hepatitis C [HCV], cytomegalovirus [CMV], Epstein Barr Virus [EBV], tuberculosis) 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. Suspicion of Covid-19 infection or 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 (including HBV, HCV, CMV, EBV, tuberculosis)
- •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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