NL-OMON55984招募中3 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 - Efficacy and safety of imlifidase in kidney transplant patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •3. Signed Informed Consent obtained before any trial related procedures
- •4. Willingness and ability to comply with the protocol
- •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)
- •of a positive crossmatch test.
- •Inclusion Criteria for patients in the non-comparative concurrent reference
- •1. Active on the renal transplant waiting list at a participating trial site at
- •the time of
- •2. An acceptable kidney transplant from a deceased donor
排除标准
- •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
- •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
- •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
- •>= 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
- •3 weeks following treatment with imlifidase. In the context of this trial, an
- •method is defined as those which result in low failure rate (i.e. less than 1%
- •when used consistently and correctly.
- •10. Any other reason that, in the view of the investigator, precludes
- •transplantation
- •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
- •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
研究者
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