EUCTR2019-004302-10-SE进行中（未招募）1 期
A randomized controlled open-label multi-center study to assess the efficacy of Tocilizumab in treatment of chronic active antibody-mediated rejection in kidney transplant recipients - InterCept
Västra Götalandsregionen, Sahlgrenska University hospital0 个研究点目标入组 50 人开始时间: 2020年4月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •1.The subject has given their written informed consent to participate in the study
- •2.Recipient of living donor or deceased donor kidney transplant
- •3.Age =18 years
- •4.At least 12 months post-transplantation at randomization
- •5.Biopsy-proven diagnosis of cAMR according to the Banff 2017 criteria in index biopsy. Repeat biopsy should be performed if the last biopsy is estimated to be older than 6 months (+ 2 weeks) at the projected time of randomization (Visit 2)
- •6.GFR =20 ml/min/1.73 m2
- •7.Epstein-Barr Virus (EBV) IgG-positive
- •8.For female participants of childbearing potential: use of adequate contraception and a negative pregnancy test
- •9.Subject known to have been previously had corona virus disease of 2019 (COVID-19) must meet all of the following conditions:
- •-Asymptomatic for at least 1 month before the start of screening
- •-Re-established on maintenance immunosuppressants for at least 2 weeks prior to the start of screening
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.Inability to tolerate any of the SOC treatment- tacrolimus, mycophenolate acid (MPA) or prednisolone
- •2.Recipient of multi-organ transplants
- •3.De novo or recurrent renal disease that, in the Investigator’s opinion, could adversely influence the current allograft
- •4.Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), SARS COV-2 (COVID-19), EBV, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections, based on polymerase chain reaction (PCR) testing
- •5.Ongoing serious infections as per Investigator’s opinion
- •6.History of recurrent serious infections requiring hospitalization
- •7.Signs of post-transplant lymphoproliferative disorder
- •8.History of tuberculosis (TB)
- •9.Active TB or latent TB (positive QuantiFERON-TB-Gold test, Chest X-ray)
- •10.Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin > 1.5 x upper limit of normal)
- •11.Other significant liver disease as per Investigator’s opinion
- •12.Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L)
- •13.Signs of malignancy. Exceptions are basal cell carcinoma/squamous cell carcinoma or non-malignant melanoma
- •14.History of malignancy, unless subject has been considered to have fully recovered from malignancy since > 2 years, without any signs of relapse
- •15.History of diverticulitis, diverticulosis, gastrointestinal perforation or inflammatory bowel disease
- •16.Ongoing alcohol or illicit substance abuse
- •17.Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator’s opinion
- •18.Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- •19.Woman of childbearing potential who is unwilling/unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
- •20.Woman with a positive pregnancy test or who is pregnant or breastfeeding
- •21.Current or recent (within last 3 months) participation in another clinical drug trial
研究者
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