CLINICAL TRIAL: TRIAL OF TACROLIMUS WITH STEROIDS AND DACLIZUMAB VS STEROID FREE

临床试验：他克莫司加类固醇和达利珠单抗与不含类固醇的试验

• 批准号: 7717085
• 负责人: VIKAS DHARNDHARKA
• 金额: $ 0.81万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717085
• 关键词: Acute; Biopsy; Bone Marrow Suppression; Cataract; Child; Childhood; Chronic; Chronic rejection of renal transplant; Clinical; Clinical Trials; Clinical assessments; Computer Retrieval of Information on Scientific Projects Database; Cosmetics; Daclizumab; Data; Diabetes Mellitus; End Point; Evaluation; Funding; Graft Survival; Grant; Growth; Height; Hyperlipidemia; Hypertension; Incidence; Infection; Institution; Kidney Transplantation; Label; Lipids; Monitor; Patients; Pattern; Pharmaceutical Preparations; Pilot Projects; Population; Protocols documentation; Research; Research Personnel; Resources; Roche brand of daclizumab; Safety; Source; Steroids; Tacrolimus; Transplant Recipients; Transplantation; United States National Institutes of Health; base; bone loss; graft function; hypercholesterolemia; prospective

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study targets the pediatric kidney transplant population where steroid avoidance has been historically complicated by loss of transplant function and occasionally outright graft loss. Steroid minimization alone has failed to make a positive impact on growth in children, and transplant recipients suffer from hypertension, high lipids, diabetes, bone loss, cosmetic disfigurement and cataracts - all directly related to chronic steroid use. This study proposes to replace steroids with an approach of prolonged induction with daclizumab, until the sixth post-transplant month. Zenapax will be the investigational product for evaluation in this study. Preliminary data from a pilot study demonstrated low incidence of clinical acute rejections, a reduction in chronic allograft nephropathy, hypertension and hypercholesterolemia and normal growth patterns post-transplantation, as compared with historical steroid-based controls. This clinical trial will be an open label multi-center prospective trial of 130 pediatric renal transplant recipients. Protocol biopsies, drug levels, immunological, histological and clinical assessments will be monitored over a 3-year period. The primary efficacy endpoint will be the difference in the change in standardized height at 1 year. The primary safety endpoint will be equivalency for biopsy proven acute rejection. The secondary endpoints will include equivalency of patient and graft survival, graft function, chronic allograft nephropathy, hypertension, hyperlipidemia, bone marrow suppression, infection, and cataracts.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项研究针对的是儿科肾移植人群，在这些人群中，类固醇回避历来因移植功能丧失和偶尔的移植物彻底丧失而变得复杂。仅减少类固醇并不能对儿童的生长产生积极影响，移植受者还患有高血压、高血脂、糖尿病、骨质流失、美容毁容和白内障——所有这些都与长期使用类固醇直接相关。这项研究建议用达珠单抗延长诱导的方法取代类固醇，直到移植后第六个月。 Zenapax 将成为本研究中进行评估的研究产品。一项试点研究的初步数据表明，与历史上基于类固醇的对照相比，临床急性排斥反应发生率较低，慢性同种异体移植肾病、高血压和高胆固醇血症减少，移植后生长模式正常。该临床试验将是一项开放标签、多中心前瞻性试验，受试者为 130 名儿童肾移植受者。方案活检、药物水平、免疫学、组织学和临床评估将在三年内进行监测。主要疗效终点是一年时标准化身高变化的差异。主要安全终点将是活检证实的急性排斥反应的等效性。次要终点包括患者和移植物存活、移植物功能、慢性同种异体移植肾病、高血压、高脂血症、骨髓抑制、感染和白内障的等效性。