CASG209: STUDY TO ASSESS SAFETY AND EFFECT OF CIDOFOVIR IN KIDNEY TRANSPLANT

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的目的是确定药物西多福韦是否可以安全地治疗BK病毒。西多福韦是该药物的通用名称，VISTIDE是品牌名称(由Gilead Sciences，Inc.制造)。尽管西多福韦已被美国食品和药物管理局(FDA)批准用于治疗巨细胞病毒(CMV)疾病，但它尚未被FDA批准用于治疗BKVN。一些已知的信息表明，肾移植患者可以安全地耐受少量的西多福韦，西多福韦可能有助于治疗BKVN。 主要目标： 1.评价三种剂量西多福韦治疗BK病毒肾病肾移植受者的安全性和耐受性。 2.确定BK病毒肾病肾移植患者三种剂量西多福韦的最大耐受量(MTD)。 3.评价西多福韦在三个剂量水平下的抗病毒作用。 4.评价西多福韦在肾移植受者中的药代动力学。

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. The purpose of this research study is to determine if the drug cidofovir might be a safe treatment against the BK virus. Cidofovir is the generic name of the drug and VISTIDE is the brand name (manufactured by Gilead Sciences, Inc.). Although cidofovir is approved by the U.S. Food and Drug Administration (FDA) for use against cytomegalovirus (CMV) disease, it has not been approved by the FDA for the treatment of BKVN. Some of the information know shows that small amounts of cidofovir might be safely tolerated in kidney transplant patients, and that cidofovir may help in treating BKVN. Primary Objectives: 1. To evaluate the safety and tolerability of three dose levels of cidofovir when administered to renal transplant recipients with BK virus nephropathy. 2. To identify the maximum tolerated doses (MTD) among the three dose levels of cidofovir in renal transplant recipients with BK virus nephropathy. 3. To evaluate the antiviral effect of cidofovir at each of the three dose levels. 4. To evaluate the pharmacokinetics of cidofovir in renal transplant recipients with underlying renal impairment.