EUCTR2018-000022-66-FR进行中（未招募）1 期
A Randomized, Open-Label, Multi-Centre, Active Control Study Investigating the Efficacy and Safety of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients
Hansa Medical AB0 个研究点目标入组 30 人开始时间: 2018年12月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
入选标准
- •1. Signed Informed Consent obtained before any study-related procedures
- •2. Willingness and ability to comply with the protocol
- •3. Male and/or female donor kidney recipients age =18 years at the time of screening
- •4. Presence of DSA(s)
- •5. Meet the Banff 2017 criteria for active AMR
- •6. At least 25% rise in serum creatinine compared to last individual value taken prior to the AMR. Patients with delayed graft function and AMR within 10 days after transplant (confirmed by kidney biopsy) can be included regardless of serum creatinine level
- •7. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method throughout the study. In the context of this study, 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; oral, intravaginal, transdermal
- •progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, 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 subject. [Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
- •8. Men willing to use double-barrier contraception from the first day of treatment until at least 2 months after the dose of imlifidase, if not abstinent
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Previous treatment with imlifidase
- •2. Previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
- •3. Lactating or pregnant females
- •4. Significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator
- •5. Intake of other investigational drugs within 5 half-lives (or similar) of the product prior to inclusion
- •6. Clinically relevant active infection(s) as judged by the investigator
- •7. Any condition that in the opinion of the investigator could increase the subject’s risk by participating in the study
- •8. Known allergy/sensitivity to IVIg and/or rituximab
- •9. Unsuitable to participate in the study for any other reason as judged by the investigator
研究者
相似试验
进行中（未招募）
1 期
A study investigating the efficacy and safety of imlifidase in eliminating donor specific antibodies in the treatment of antibody-mediated rejection in kidney Transplant patientsAntibody-mediated rejection in kidney transplant patientsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersEUCTR2018-000022-66-DEHansa Biopharma30
进行中（未招募）
1 期
A study investigating the efficacy and safety of imlifidase in eliminating donor specific antibodies in the treatment of antibody-mediated rejection in kidney Transplant patientsAntibody-mediated rejection in kidney transplant patientsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersEUCTR2018-000022-66-ATHansa Biopharma30
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisRelapsing Remitting Multiple Sclerosis (RRMS)MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2018-003008-38-BGBiogen Idec Research Limited142
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisRelapsing Remitting Multiple Sclerosis (RRMS)MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2018-003008-38-ITBIOGEN IDEC RESEARCH LIMITED142
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisEUCTR2018-003008-38-HUBiogen Idec Research Limited142