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

临床试验：他克莫司联合类固醇和达利珠单抗与类固醇 FRE 的试验

• 批准号: 7950711
• 负责人: Vikas R. Dharnidharka
• 金额: $ 0.08万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950711
• 关键词: 21 year old; Acute; Biopsy; Bone Marrow Suppression; Cataract; Child; Childhood; Chronic; Chronic rejection of renal transplant; Clinical; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cosmetics; Daclizumab; Data; Diabetes Mellitus; Funding; Graft Survival; Grant; Growth; Height; Hyperlipidemia; Hypertension; Immunosuppression; Incidence; Infection; Institution; Kidney Transplantation; Lipids; Morbidity - disease rate; Organ Transplantation; Patients; Pattern; Pilot Projects; Population; Protocols documentation; Randomized; Research; Research Personnel; Resources; Safety; Solid; Source; Steroids; Tacrolimus; Transplant Recipients; Transplantation; United States National Institutes of Health; base; bone loss; graft function; hypercholesterolemia; mycophenolate mofetil; open label; 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 protocol aims to remove the morbidity of chronic steroid usage that has accompanied solid organ transplantation. This study targets the pediatric kidney transplant population where steroid avoidance has been complicated by loss of transplant function and occasionally outright graft loss. Steroid minimization 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 - related to chronic steroid use. This study proposes to replace steroids with a first ever approach of prolonged induction with daclizumab, until the sixth post-transplant month. 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, 0 to 21 years of age, randomized with a ratio of 1:1 to a traditional steroid-based immunosuppression protocol, steroids, standard daclizumab induction until the second post transplant month, tacrolimus and Mycophenolate Mofetil-MMF verses a steroid-free immunosuppression protocol proposed, prolonged daclizumab induction until the sixth post transplant month, tacrolimus and MMF. 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 该方案旨在消除伴随实体器官移植的慢性类固醇使用的发病率。本研究针对儿童肾移植人群，在这些人群中，由于移植功能丧失和偶尔的移植物完全丧失而使避免类固醇变得复杂。类固醇最小化未能对儿童的生长产生积极影响，移植受者患有高血压、高血脂、糖尿病、骨质流失、美容毁容和白内障-与长期使用类固醇有关。这项研究建议用第一种用daclizumab延长诱导的方法取代类固醇，直到移植后第六个月。 一项初步研究的初步数据表明，临床急性排斥反应的发生率低，慢性移植肾肾病，高血压和高胆固醇血症和正常生长模式后减少？移植，与历史类固醇为基础的对照相比。本临床试验将是一项开放标签多中心前瞻性试验，纳入130名0至21岁的儿童肾移植受者，以1：1的比例随机分配至传统的基于类固醇的免疫抑制方案、类固醇、标准达克珠单抗诱导直至移植后第二个月、他克莫司和吗替麦考酚酯-霉酚酸酯-推荐的无类固醇免疫抑制方案 主要疗效终点为1年时标准身高变化的差异。主要安全性终点将是活检证实的急性排斥反应的等效性。次要终点将包括患者和移植物存活、移植物功能、慢性同种异体移植物肾病、高血压、高脂血症、骨髓抑制、感染和白内障的等效性。