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

这个子项目是众多研究子项目之一

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.