JPRN-jRCT2080224107已完成3 期
Phase III study for evaluating efficacy and safety of desensitization based on IDEC-C2B8 in living donor kidney transplantation recipients with pre-formed anti-HLA antibody and/or donor-specific antibody. Phase III study for evaluating efficacy, safety and pharmacokinetics of pre-transplant administration of FK506 or FK506E(MR4) for 7 to 28 days in living donor kidney transplantation recipients.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
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
- >= 16age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •[Recipients]
- •1.Japanese recipients who are scheduling the living kidney transplantation.
- •2.Recipients with pre-formed anti-HLA antibody and/or donor-specific antibody.
- •3.Recipients who are 16 - 75 years of age at giving written informed consent.
- •4.Recipients or Recipient's representative who are able to understand the study protocol and provide the written informed consent.
- •1.Donors who are selected by the Inclusion criteria and the Exclusion criteria defined by the each medical institution according to the Consensus Statement of the Amsterdam Forum (2004), the guideline of living donor kidney transplantation (the Japan Society for Transplantation), donor guideline of living donor kidney transplantation (the Japan Society for Transplantation and the Japan Society for Clinical Renal Transplantation) and the ethical guideline of the Japan Society for Transplantation.
排除标准
- •1.Recipients who have a history of Hypersensitivity or severe allergic to murine products.
研究者
相似试验
已完成
3 期
Phase III study for evaluating efficacy and safety of a combination treatment of IDEC-C2B8 with steroid pulse therapy and plasmapheresis for antibody-mediated rejection after kidney transplant.JPRN-jRCT2080224105ZENYAKU KOGYO CO., LTD.20
进行中（未招募）
1 期
A study to assess the efficacy and safety of Dupilumab in patients with severe atopic dermatitis (AD) that are not controlled with oral cyclosporine A (CSA) or for those who cannot take oral CSA because it is not medically advisableMedDRA version: 18.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic dermatitisEUCTR2015-002653-35-IERegeneron Pharmaceuticals, Inc.330
进行中（未招募）
1 期
A study to assess the efficacy and safety of Dupilumab in patients with severe atopic dermatitis (AD) that are not controlled with oral cyclosporine A (CSA) or for those who cannot take oral CSA because it is not medically advisableAtopic dermatitisEUCTR2015-002653-35-NLRegeneron Pharmaceuticals, Inc.330
进行中（未招募）
1 期
A study to assess the efficacy and safety of Dupilumab in patients with severe atopic dermatitis (AD) that are not controlled with oral cyclosporine A (CSA) or for those who cannot take oral CSA because it is not medically advisableMedDRA version: 19.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic dermatitisEUCTR2015-002653-35-BERegeneron Pharmaceuticals, Inc.330
进行中（未招募）
1 期
A study to assess the efficacy and safety of Dupilumab in patients with severe atopic dermatitis (AD) that are not controlled with oral cyclosporine A (CSA) or for those who cannot take oral CSA because it is not medically advisableMedDRA version: 19.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic dermatitisEUCTR2015-002653-35-ESRegeneron Pharmaceuticals, Inc.330