PK OF MYCOPHENOLATE MOFETIL W/ VALGANCICLOVIR IN RENAL & HEART TRANSPL RECIPENT

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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 study is to evaluate the effects of valganciclovir (VGCV) on how the body handles mycophenolate mofetil (MMF) in kidney and heart transplant patients. VGCV and MMF are FDA-approved drugs given to kidney and heart transplant patients: VGCV to prevent cytomegalovirus infection and MMF to suppress their immune system to their body does not reject the transplanted organ. Active forms of MMF and VGCV are cleared through the kidney, but there is no data on how VGCV effects MMF concentrations in the body when two drugs are given together. Because both MMF and VGCV cause similar side effects, clinicians are often challenged when making decisions regarding whether the dosage of one or both rugs should be reduced. The 12-hour blood studies to measure drug concentrations will be conducted on 2 occasions: 1st study during MMF and VGCV therapy and 2nd study with MMF alone after VGCV discontinuation. The results of this study will help clinicians develop dosing guidelines if there is an interaction between MMF and VGCV.'