This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000048-45S1
Application #
7604319
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-12-01
Project End
2007-11-30
Budget Start
2006-12-01
Budget End
2007-11-30
Support Year
45
Fiscal Year
2007
Total Cost
$457
Indirect Cost
Name
Northwestern University at Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611
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