MYCOPHENOLATE MOFETIL AND ANTI-HLA ANTIBODY LEVELS IN CADAVERIC RENAL TRANSPLANT

尸体肾移植中霉酚酸酯和抗 HLA 抗体水平

• 批准号: 7603441
• 负责人: CONNIE L DAVIS
• 金额: $ 2.04万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603441
• 关键词: Antibodies; Antibody Formation; Blood; Computer Retrieval of Information on Scientific Projects Database; Dialysis patients; Dose; Drug Kinetics; Funding; Grant; Hour; Institution; Kidney Transplantation; Label; Lead; Measurement; Measures; Mycophenolate; Organ Donor; Patients; Prospective Studies; Quality of life; Research; Research Personnel; Resources; Sampling; Source; Standards of Weights and Measures; Time; Transplantation; United States National Institutes of Health; Waiting Lists; follow-up; mycophenolate mofetil

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. HICAD-MMF: Highly sensitized patients remain on the cadaveric renal transplant waiting list for years because they do not find a negatively cross-matched donor organ. Poor survival and reduced quality of life result. The overall objectives of this study are to determine if mycophenolate mofetil (MMF) (i) can decrease anti HLA antibody production in highly sensitized patients on the cadaveric renal transplant waiting list, (ii) can lead to earlier transplantation compared to historic control patients and (iii) is safe to give to dialysis patients. This is an open label prospective study in which 30 patients with panel reactive antibody titers exceeding 50% for at least 6 months at baseline receive MMF and are followed for up to 12 months MMF Pharmacokinetics: Mycophenolate mofetil steady-state pharmacokinetics will be performed on 15 subjects. The sampling times will be as follows: Pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10 and 12 hours post-dosing. Measured at each time point will be total MPA and MPAG. Additionally, free MPA would be measured pre-mycophenolate dose and one hour post-dose. With these measurements, standard, steady state, non-compartment analysis of the pharmacokinetics will be done. We will be able to evaluate Cmax, Tmax, AUC and CL/F and the fraction of MPA unbound at trough and peak concentrations. Approximately 70mls of blood will be drawn from each subject for the pharmacokinetics.

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