PK-PD MODELS OF MYCOPHENOLIC ACID

霉酚酸的 PK-PD 模型

• 批准号: 7607792
• 负责人: Alexander A Vinks
• 金额: $ 0.11万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7607792
• 关键词: Adverse event; Age; Blood specimen; Caring; Cellcept; Child; Clinical; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Funding; Grant; Hour; Immunosuppression; Individual; Inpatients; Institution; Kidney Transplantation; Laboratories; Lead; Measurement; Modeling; Mycophenolic Acid; Outcome; Outpatients; Patients; Pharmaceutical Preparations; Physical Examination; Purpose; Research; Research Personnel; Resources; Safety; Screening procedure; Source; Standards of Weights and Measures; Therapeutic immunosuppression; Time; Transplantation; United States National Institutes of Health; Visit; Whole Blood; base; day

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 determine how fast children (age 2-17 years), who have had a recent kidney transplant, absorb, breakdown and eliminate mycophenolic acid (CellCept) following their prescribed dose and how this influences their level of immunosuppression. Subjects will have been receiving CellCept as part of their clinical standard of care. It is anticipated that the clinical portion of the study for each patient will be approximately six months post kidney transplant with four study days: a screening visit pre-transplant, two 10-hour inpatient days at 2-3 and 6-9 days post-transplant, and one (up to 10 hour) outpatient visit at 3-6 months post-transplant. Whole blood samples for drug and effect measurements will be collected at various time points (up to 9 hours post dose) on study days 2, 3, and 4. Safety data to be collected will include physical examinations, measurement of vital signs, and laboratory assessments, as well as data on adverse events and clinical outcomes. The results of this study will lead to better dosing based on individual needs.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是确定最近接受过肾移植的儿童（年龄2-17岁）在处方剂量后吸收，分解和消除霉酚酸（CellCept）的速度以及这如何影响他们的免疫抑制水平。受试者将接受头孢噻肟作为其临床标准治疗的一部分。预计每例患者的研究临床部分将在肾移植后约6个月进行，共4个研究日：移植前筛选访视，移植后2-3天和6-9天的两个10小时住院日，以及移植后3-6个月的一次（最多10小时）门诊访视。将在研究第2、3和4天的不同时间点（给药后9小时内）采集用于药物和效应测量的全血样本。收集的安全性数据将包括体格检查、生命体征测量和实验室评估，以及不良事件和临床结局数据。 本研究的结果将根据个体需求提供更好的剂量。